RF Denervation Electrode with Dissipating Polymer Layer
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Solution Overview
Problem
Current renal denervation devices using metallic electrodes for RF energy application face issues such as procedural damage to the renal artery endothelium, irreversible electroporation, surface electrolysis, and increased thrombus formation due to concentrated RF fields and partial electrode contact with blood flow.
Innovation Solution
The use of an RF treatment device with a polymeric or ceramic RF dissipating material layer between the metallic conductor and body tissues, which blocks RF electric fields and reduces heat transfer concentration, minimizing endothelial damage and thrombotic risks, while maintaining effective neuromodulation through controlled heat transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If metallic electrodes are used for RF energy application in renal denervation, then effective neuromodulation is achieved, but procedural damage to the renal artery endothelium occurs
Solution Approach 1:
A non-conductive coating layer is applied to the electrode surface to act as an intermediary between the metallic electrode and the endothelium. This coating blocks direct exposure to RF electric fields while allowing controlled heat transfer, thereby preventing endothelial damage through mechanisms such as preventing irreversible electroporation and surface electrolysis while maintaining denervation efficacy.
2Reliability
If RF fields are concentrated at the tissue surface during renal denervation, then effective nerve blocking is achieved, but irreversible electroporation and surface electrolysis occur
Solution Approach 1:
The non-conductive coating serves as a mediator that distributes and controls the RF field interaction. It prevents concentrated RF field effects at the tissue surface by blocking direct field contact, thereby preventing irreversible electroporation while still enabling sufficient heat transfer for effective nerve blocking through controlled thermal conduction.
3Ease of operation
If partial contact of the electrode with blood flow occurs during renal denervation, then procedural flexibility is maintained, but coagulation and thrombus formation increase
Solution Approach 1:
The non-conductive coating acts as a protective intermediary between the electrode and blood flow. It prevents direct exposure of blood to concentrated resistive heating zones, thereby eliminating coagulation and thrombus formation risks while allowing the electrode to maintain partial contact with blood flow for procedural flexibility and positioning adaptability.
Solution Approach 2:
The coating transforms a potentially harmful situation (partial electrode contact with blood) into a safe procedure. By blocking direct RF field exposure to blood, the coating converts the risk of thrombus formation into an opportunity for safe, flexible electrode positioning without compromising procedural 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
This solution reduces endothelial damage, minimizes thrombotic risks, and allows for lower operating temperatures, thereby improving the safety and efficacy of renal denervation procedures by preventing direct exposure to RF electric fields and reducing thermal damage.
Implementation Method 1
a layer of an RF dissipating material overlying the conductor so that the layer of RF dissipating material is disposed between the conductor and body tissues
Implementation Method 2
heat transfer across the arterial wall, from endothelium to adventitia, results in denervation of the renal nerve
Data Source
AI summary
A renal denervation device can include an elongated catheter body extending along a longitudinal axis, and an assembly connected to the catheter body. The assembly includes a plurality of heating elements connected to the catheter body. Each heating element has a conductor and a layer of an RF dissipating material such as a polymer overlying the conductor. During operation of the device, the layer of RF dissipating material is disposed between the conductor and body tissues of a subject. The layer of RF dissipating material is substantially thicker than the Debye length within the material in order to reduce the electric field reaching the tissue and to eliminate direct contact of the electrode with the body tissue.