Steerable Guide Wire Stent Delivery System
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Solution Overview
Problem
Current stent delivery systems require a separate guide wire for placement, increasing procedure time and cost, and are less effective in tortuous coronary arteries due to the need for pre-dilatation and the use of non-steerable guide wires.
Innovation Solution
A stent delivery system featuring a steerable guide wire coaxially enclosed in a thin-walled guide wire tube, integrated with a balloon angioplasty catheter, allowing for reduced diameter and eliminating the need for a separate guide wire, with a lubricity-coated distal seal for easier passage through stenoses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate guide wire is used for stent delivery, then the guide wire can be placed through the stenosis, but the procedure time increases and additional cost is incurred
Solution Approach 1:
The patent combines the guide wire function and stent delivery function into a single integrated device. The stent delivery catheter incorporates a guide wire lumen that allows a guide wire to pass through, while simultaneously serving as the delivery system for the stent. This eliminates the need for a separate guide wire placement step, reducing procedure time while maintaining the capability to navigate through stenoses.
2Device complexity
If a fixed non-steerable guide wire is used, then the structure is simple, but the system is less capable for rapid delivery through tortuous coronary arteries
Solution Approach 1:
The patent incorporates a steerable guide wire with a shape memory alloy construction that allows the guide wire to dynamically change its configuration. The guide wire can be manipulated to assume different shapes (straight or curved) depending on the vascular anatomy, enabling navigation through tortuous coronary arteries while maintaining structural integrity and deliverability.
3Ease of operation
If a traditional inner shaft is used for guide wire placement, then the guide wire can be advanced, but the deflated balloon diameter cannot be reduced
Solution Approach 1:
The patent segments the delivery system into distinct functional components: an outer catheter shaft, an inner guide wire lumen, and a balloon assembly. This segmentation allows the balloon to be positioned within the guide wire lumen rather than requiring a large central shaft, enabling the deflated balloon to have a reduced diameter for better deliverability while still allowing guide wire advancement through the integrated lumen.
4Reliability
If pre-dilatation is performed before stent placement, then the stenosis is opened, but the procedure time increases and direct stenting cannot be achieved
Solution Approach 1:
The patent employs a balloon with optimized parameters including a compliant construction and specific diameter ratios that allow the stent to be delivered and deployed directly into the stenosis without prior dilation. The balloon's compliance and size parameters are designed to facilitate direct stenting while still providing adequate support for stent deployment, thereby improving procedure efficiency while maintaining stenosis patency.
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 direct stenting without pre-dilation, reduces procedure time and cost, and enhances accessibility through tortuous arteries with a minimally profiled system that can efficiently deploy stents in tight stenoses.
Implementation Method 1
a lubricity-coated distal seal for easier passage through stenoses
Data Source
AI summary
A thin-walled guide wire tube is fixedly and sealably attached to both a proximal section and a distal section of a balloon angioplasty catheter. A stent is co-axially mounted onto the inflatable balloon of the balloon angioplasty catheter. Because the guide wire tube forms an inner liner for the balloon angioplasty catheter, the fluid inflation lumen of the catheter is sealed so the inflation liquid that pressurizes the balloon will not leak as it would be if there were no “inner liner” and the balloon angioplasty catheter were attached to the guide wire itself. By not having a traditional inner shaft through which a conventional guide wire slides, the deflated balloon on which the stent is mounted can have a reduced diameter.