Helical Balloon Catheter for Vascular Flow Control
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Solution Overview
Problem
Current stents and balloon catheters fail to effectively prevent thrombosis, atherosclerosis, and intimal hyperplasia due to planar geometry, which leads to low wall shear stress and recirculation areas, promoting in-stent restenosis and ingrowth of intima.
Innovation Solution
A helically shaped balloon catheter with varying helical angles in its expanded configuration, which induces a swirling blood flow pattern in the blood vessel, reducing low wall shear stress areas and minimizing thrombosis and intimal hyperplasia, while also providing alignment markers for precise stent deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a planar balloon geometry is used for stent expansion, then the device structure is simple and easy to manufacture, but it creates low wall shear stress areas and recirculation zones that promote thrombosis and in-stent restenosis
Solution Approach 1:
The balloon is designed with a helical three-dimensional geometry instead of a planar shape. The longitudinal axis of the balloon curves in a helical pattern along its length, creating a non-planar configuration that induces swirling blood flow when expanded. This curvature transforms the flow pattern from laminar with recirculation zones to a swirling flow that maintains higher wall shear stress along the vessel wall, thereby reducing thrombosis and restenosis risk.
Solution Approach 2:
The invention transitions from a two-dimensional planar balloon geometry to a three-dimensional helical structure. The longitudinal axis of the balloon is configured to curve in three-dimensional space, adding a spatial dimension to the expansion geometry. This dimensional change allows the balloon to create a more complex flow pattern that eliminates recirculation zones and promotes beneficial wall shear stress distribution.
2Object-affected harmful factors
If a helical three-dimensional balloon geometry is used, then wall shear stress is increased and thrombosis is reduced, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The balloon geometry is defined by specific parameters including the helical angle (α) that varies along the length of the balloon, the radius of curvature (R), and the pitch of the helix. By controlling these parameters, the design achieves the desired helical configuration that generates beneficial flow patterns. The varying helical angle allows optimization of wall shear stress distribution while maintaining manufacturability through precise parameter specification.
3Object-affected harmful factors
If the balloon longitudinal axis is curved in three-dimensional space, then blood flow undergoes swirling action that minimizes platelet adhesion, but the delivery profile and navigation through vessels becomes more challenging
Solution Approach 1:
The balloon is designed to be expandable from a collapsed low-profile configuration to an expanded three-dimensional helical configuration. In the collapsed state, the balloon maintains a simple linear profile that facilitates easy delivery through catheters and navigation through vessels. Upon inflation, it dynamically transforms into the complex helical shape that generates beneficial swirling flow patterns, thus achieving both easy delivery and therapeutic effect.
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 helically shaped balloon catheter reduces thrombosis and intimal hyperplasia by creating a swirling blood flow, inhibiting vascular diseases and ensuring proper stent alignment, thereby minimizing in-stent restenosis and ingrowth of intima.
Implementation Method 1
Blood flowing through the three-dimensional curved part of the blood vessel undergoes a swirling action. The swirling flow of blood has been found to minimise thrombosis and platelet adhesion
Data Source
Figure 1~2(a)
Figure 3~6
Figure 7~10
AI summary
A stent deployment device comprises an elongate catheter shaft (2), and an inflatable balloon (3). The inflatable balloon (3) is movable between a collapsed configuration and an expanded configuration. In the expanded configuration part of the longitudinal axis of the balloon (3) is curved in three-dimensional space, and part of the balloon (3) is helically shaped. A stent (6) is movable from a collapsed delivery configuration to a partially expanded intermediate configuration, and subsequently from the intermediate configuration to a fully expanded deployed configuration. In the delivery configuration the longitudinal axis of the stent (6) is straight. The longitudinal axis of the stent (6) may be straight or curved in three-dimensional space in the intermediate configuration. In the deployed configuration the longitudinal axis of the stent (6) is curved in three-dimensional space. The balloon (3) in the expanded configuration exerts force on the stent (6). In the deployed configuration the stent (6) in turn exerts force on the internal wall of a blood vessel (5) causing the longitudinal axis of the blood vessel (5) to curve in three-dimensional space.