Deformable Biliary Stent for Antegrade Placement and Retention
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Solution Overview
Problem
Current bile duct surgery methods, particularly for stent placement, face challenges such as prolonged imaging and placement times, difficulty in retaining stents, and complications from multiple interventions, including high complication rates and limited access to specialized endoscopists.
Innovation Solution
Development of a deformable biliary stent with a tubular body that transitions from a tensioned linear delivery configuration to an expanded helical deployment configuration, utilizing a polymeric material with specific mechanical properties to securely anchor within the bile duct, allowing for simplified, antegrade stent placement and reduced operative time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional retrograde ERCP is used for stent placement, then specialist intervention is available, but complication rate increases to 10-13%
Solution Approach 1:
The patent inverts the traditional retrograde approach by implementing antegrade stent placement through the cystic duct. Instead of accessing the bile duct from the duodenum (retrograde), the stent is delivered from the gallbladder side through the cystic duct into the common bile duct (antegrade), thereby avoiding the complications associated with retrograde sphincterotomy and cannulation.
Solution Approach 2:
The patent uses a delivery catheter as an intermediary device to transport the stent through the cystic duct and into the common bile duct. This intermediary tool enables controlled stent deployment without requiring direct endoscopic manipulation, reducing the risk of complications while maintaining placement accuracy.
2Reliability
If common bile duct exploration is performed to clear stones, then bile duct can be cleared, but operative time and equipment setup time increase significantly
Solution Approach 1:
The patent combines stone removal and stent placement into a single integrated procedure. The delivery catheter serves dual purposes: it can be used to extract stones from the common bile duct and subsequently deploy a stent to prevent recurrence, eliminating the need for separate procedures and reducing total operative time.
Solution Approach 2:
The delivery catheter is designed as a multi-functional device that can perform multiple tasks including stone extraction, stent delivery, and bile duct imaging. This universal tool consolidates what would traditionally require multiple specialized instruments and procedures, streamlining the surgical workflow.
3Productivity
If percutaneous antegrade stent placement is used, then single procedure is possible, but stent retention is difficult and dislodgement occurs
Solution Approach 1:
The patent employs a curved or angled stent design that conforms to the natural anatomy of the bile duct and cystic duct junction. This curvature allows the stent to engage better with the ductal walls, preventing dislodgement while maintaining the streamlined profile needed for delivery through the catheter.
Solution Approach 2:
The stent features localized retention elements such as flares or expansion zones at specific locations (e.g., the proximal end in the gallbladder fossa and distal end in the common bile duct). These localized structural variations provide anchoring points that enhance retention without compromising the overall delivery mechanism.
4Reliability
If multiple tools and access points are used for stent placement, then stent can be placed, but device complexity and procedure difficulty increase
Solution Approach 1:
The delivery catheter is designed as a universal device that integrates multiple functions: it serves as the access tool, the stent carrier, the deployment mechanism, and the retention structure. This single multi-functional device replaces what would traditionally require multiple separate tools including guidewires, delivery sheaths, and deployment devices.
Solution Approach 2:
The stent is nested within the delivery catheter in a compact configuration, allowing it to pass through the cystic duct and into the common bile duct without requiring separate access points or additional tools. The nested design enables the stent to be transported and deployed through a single catheter tract, simplifying the overall procedure.
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 stent facilitates rapid and reliable bile duct access, reduces complications, and enables simultaneous imaging and stent placement, minimizing exposure to noxious fumes and aerosols, while allowing for subsequent endoscopic removal.
Implementation Method 1
the polymeric material has a Young's modulus that is effective to... exert a radially expansive force on an inner wall of a bile duct to radially expand the inner wall of the bile duct so retain the tubular body in the bile duct
Implementation Method 2
the polymeric material has a Young's modulus that is effective to... exert a frictional force on an antegrade delivery device to so retain the tubular body on the delivery device
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.