Rapid Exchange Stent Delivery System with Nested Balloon
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Solution Overview
Problem
Current medical devices for delivering stents to the biliary and pancreatic tracts lack alternatives in design, materials, and manufacturing methods, limiting their effectiveness and versatility in medical procedures.
Innovation Solution
A medical device comprising an elongate tubular member with an endosurgery stent on its outer surface, a push tube, and a push member slidably disposed within the tubular member, featuring a guidewire ramp and multiple lumens for independent use, allowing for rapid exchange and precise deployment of stents, along with materials like nickel-titanium alloys and radiopaque materials for enhanced performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a traditional stent delivery system is used, then the stent can be delivered to the target site, but the exchange and deployment process is time-consuming and complex
Solution Approach 1:
The delivery system is divided into distinct functional segments: an elongate catheter for navigation, a compressible stent for delivery, a balloon catheter for expansion, and a guidewire for positioning. This segmentation allows each component to perform its specific function efficiently, enabling rapid stent exchange and deployment while maintaining overall system manageability
Solution Approach 2:
The stent is compressed and nested within the catheter lumen for delivery. The balloon catheter is positioned within the stent structure, and the entire assembly is guided by the guidewire. This nested configuration allows all components to be delivered through a single access point and enables sequential deployment without requiring complex external manipulation
2Manufacturing precision
If a simple delivery system is used, then the device complexity is reduced, but the precision and control during stent deployment are compromised
Solution Approach 1:
The balloon catheter serves as an intermediary mechanism between the operator and the stent. By inflating the balloon within the compressed stent, the operator can precisely control the expansion timing and location. The guidewire acts as an intermediary for positioning, allowing accurate navigation to the target site before stent deployment. These intermediary components enable precise placement without requiring the entire system to be overly complex
3Adaptability or versatility
If multiple components are integrated in the delivery system, then the functionality and versatility are improved, but the ease of operation is reduced
Solution Approach 1:
The stent is pre-compressed within the catheter and the balloon is pre-positioned within the stent structure before reaching the target site. The guidewire is预先 placed to establish the correct pathway. This preliminary preparation of all components allows the operator to simply trigger the deployment sequence without needing to manually manipulate multiple independent elements during the critical deployment phase, thereby maintaining ease of operation despite the system's versatility
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 device enables efficient and precise stent deployment in the biliary and pancreatic tracts, facilitating improved drainage and intervention capabilities while maintaining compatibility with imaging technologies and ensuring durability and visibility during procedures.
Implementation Method 1
The stent may be made from a variety of different materials including, but not limited to, metals, metal alloys, polymers, and combinations thereof. In a particular embodiment, the stent is made from a self-expanding material such as nickel-titanium alloy.
Implementation Method 2
The device features a guidewire ramp and multiple lumens for independent use, allowing for rapid exchange and precise deployment of stents, along with materials like nickel-titanium alloys and radiopaque materials for enhanced performance.
Data Source
AI summary
Medical devices and methods for making and using the same. An example medical device may include an elongate tubular member, an endosurgery stent disposed on the outer surface of the tubular member, a push tube slidably disposed along the outer surface of the tubular member, and a push member slidably disposed in a lumen formed in the tubular member. The push member may be coupled to the push tube.