Conformable Stents via Balloon Groove Injection
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Solution Overview
Problem
Existing angioplasty methods face challenges in effectively treating stenosis in blood vessels, particularly in irregularly shaped areas and bifurcations, where traditional stents may not conform properly to non-uniform vessel diameters and complex anatomy.
Innovation Solution
A method involving a balloon with preformed grooves on its surface is inserted into a blood vessel, inflated at the stenosis site, and a fluid substance is injected into these grooves to form a stent, which hardens in place, conforming to the vessel's shape and maintaining patency, even at bifurcations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If traditional stents are used in angioplasty procedures, then the procedure can be performed with standard equipment, but the stents cannot conform properly to irregularly shaped areas and non-uniform vessel diameters
Solution Approach 1:
The balloon is pre-formed with grooves on its surface before insertion into the vessel. These grooves are created in advance to guide the fluid substance and form the stent scaffold in the desired configuration, allowing the stent to conform to irregular vessel shapes without requiring complex post-deployment adjustments
Solution Approach 2:
The invention uses a fluid substance that changes its physical state from liquid to solid (hardening) to transform the stent structure. This parameter change allows the stent to be injected in a fluid state to conform to irregular geometries, then hardened to maintain structural integrity, resolving the contradiction between conformability and structural complexity
2Reliability
If traditional stents are used to maintain vessel patency, then the vessel can be kept open, but the stents do not fit well at bifurcations and complex anatomical locations
Solution Approach 1:
The grooves on the balloon surface are strategically positioned and configured to create different stent structures at different locations. This allows the stent to have varying densities, patterns, and configurations tailored to specific anatomical requirements such as bifurcations, ensuring reliable patency maintenance while adapting to complex local anatomy
Solution Approach 2:
The balloon grooves are pre-configured to match the expected anatomical geometry at bifurcations and complex areas. By preparing the mold structure in advance, the stent automatically conforms to the complex anatomy during deployment, improving both adaptability and reliability without requiring complex delivery systems
3Adaptability or versatility
If multiple stent sizes are used to treat different vessel diameters, then various vessel sizes can be accommodated, but the procedure requires multiple stent types and increases complexity
Solution Approach 1:
The balloon is designed to be expandable to different sizes, and the grooves on its surface are configured to create stents of varying diameters and densities. By dynamically adjusting the balloon expansion, a single stent delivery system can accommodate various vessel diameters, eliminating the need for multiple fixed-size stents and reducing overall device complexity
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
This approach allows for the creation of stents that precisely fit irregularly shaped areas, maintaining vessel patency and improving blood flow, especially in complex anatomical locations where traditional stents may fail, without the need for multiple stent sizes or additional support.
Implementation Method 1
The injected substance can harden at bodily temperature
Data Source
AI summary
Materials and methods for making conformable stents. The stents can be generated by, for example, injecting a fluid into a scaffold on the outer surface of an angioplasty balloon inflated at the site of a stenosis, and allowing the fluid to harden or set, thus generating a stent that can remain in the vessel at the site of stenosis.