Helical Shaping Structure for Renal Denervation Energy Delivery
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Solution Overview
Problem
Current methods for renal nerve ablation in treating congestive heart failure and chronic renal failure face challenges in achieving uniform electrode contact and maintaining consistent energy delivery, leading to inefficiencies and potential complications such as stenosis formation.
Innovation Solution
A helical shaping structure is developed to support electrodes within the renal artery, allowing for non-continuous circumferential energy application, reducing the risk of stenosis and enhancing electrode apposition control through a method involving a mandrel with specific hole configurations and a metal wire wrapping process, using shape memory alloys for improved flexibility and uniform pressure distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If continuous circumferential energy application is used for renal nerve ablation, then complete denervation is achieved, but stenosis formation risk increases
Solution Approach 1:
The continuous circumferential energy application is divided into multiple discrete energy delivery zones spaced around the renal artery circumference. This segmentation allows complete denervation through multiple focal points while leaving healthy tissue between zones, thereby reducing the risk of stenosis formation that would result from continuous circumferential ablation.
2Manufacturing precision
If electrode contact pressure is increased to improve energy delivery uniformity, then energy delivery consistency improves, but vessel wall damage risk increases
Solution Approach 1:
The electrode structure incorporates varying contact pressures at different circumferential positions, with higher pressure applied at zones where better contact is needed and lower pressure where the vessel wall is more vulnerable. This local quality approach ensures uniform energy delivery where required while preventing vessel wall damage in sensitive areas.
3Device complexity
If a simple electrode structure is used, then device complexity is reduced, but electrode apposition control deteriorates
Solution Approach 1:
The electrode structure incorporates expandable elements that can dynamically adjust their configuration to match the renal artery geometry. This dynamic adaptation allows the relatively simple electrode structure to achieve optimal apposition control by conforming to the vessel shape, balancing structural simplicity with operational effectiveness.
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 helical shaping structure ensures stable and uniform energy delivery to the renal nerves, reducing the risk of stenosis and improving the effectiveness of renal neuromodulation treatments by maintaining consistent contact and distributing pressure evenly across the vessel wall.
Implementation Method 1
heating the mandrel and the wire. In some embodiments, wrapping a metal wire around the mandrel includes wrapping a wire formed of shape memory metal, which may be in some embodiments, a wire formed of a Nickel Titanium alloy
Data Source
AI summary
A method for manufacturing a shaping structure having a generally helical profile and configured to support electrodes for delivering electric energy into a cylindrical lumen of a patient. The method comprises providing a mandrel with a circular cylindrical shape and forming a first hole in the mandrel along the elongate axis, such that opposing ends of a bore of the first hole emerge at the proximal end and at the distal end; forming a second hole in the mandrel to extend from the curved surface to connect with the first hole; wrapping a metal wire around the mandrel; and inserting opposing ends of the metal wire into the second and the third hole respectively, and threading the opposing ends of the metal wire until they emerge from the opposing ends of the bore of the first hole; finally, heating the mandrel and the wire.