Renal Nerve Modulation via Segmented Impedance Control
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Solution Overview
Problem
Current renal nerve ablation techniques using radiofrequency energy face challenges in consistency due to varying tissue types, leading to inconsistent lesion depth and risk of unintended burns, particularly when muscular, fatty, and connective tissues are present.
Innovation Solution
A medical device system with an elongate shaft and ablation electrodes, coupled with multiple ground pads and a processor to adjust impedance, ensuring even energy distribution and reducing variability in lesion size and depth by forming uniform electrical circuits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If radiofrequency energy is used to ablate perivascular renal nerves, then nerve ablation can be achieved, but lesion consistency deteriorates due to variable tissue types (muscle, connective tissue, fat)
Solution Approach 1:
The patent divides the single return path into multiple segmented return paths by providing multiple return electrodes distributed along the catheter shaft. Each ablation electrode forms an independent electrical circuit with its own return electrode, allowing independent control of energy delivery to each tissue site, thereby achieving consistent lesions despite variable tissue types.
Solution Approach 2:
The patent applies local quality by positioning return electrodes in specific locations along the catheter shaft to create localized electrical circuits. Each circuit is configured with specific electrode spacing and orientation tailored to the local tissue anatomy, ensuring optimal energy distribution and consistent lesion formation at each treatment site.
2Manufacturing precision
If multiple ground pads are used to improve energy distribution, then lesion consistency improves, but device complexity increases
Solution Approach 1:
The catheter shaft serves multiple functions: it provides structural support, acts as an electrical insulator, and hosts both ablation electrodes and return electrodes along its length. This multi-functionality allows the device to achieve precise energy distribution through multiple electrodes without proportionally increasing overall device complexity.
Solution Approach 2:
The patent creates multiple equipotential return paths along the catheter shaft, where each return electrode is positioned to establish an electrical circuit with approximately equal impedance characteristics. This equipotential design ensures balanced energy distribution across multiple circuits, achieving uniform lesion formation while maintaining manageable device complexity.
3Reliability
If energy delivery is increased to ensure adequate ablation, then treatment effectiveness improves, but risk of unintended burns increases
Solution Approach 1:
By segmenting the energy delivery into multiple independent circuits, each circuit delivers controlled energy to a specific localized area. This prevents excessive energy accumulation that could cause unintended burns, while ensuring adequate ablation at each target site through focused energy delivery.
Solution Approach 2:
The patent enables monitoring of electrical circuit parameters (impedance, current, voltage) for each independent circuit, allowing real-time feedback control of energy delivery. This feedback mechanism ensures energy is delivered at effective levels for ablation while automatically preventing excessive energy that could cause unintended burns.
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 system achieves more consistent and controlled renal nerve ablation by evenly distributing energy across multiple ground pads, minimizing unintended lesions and improving treatment consistency across different anatomical conditions.
Implementation Method 1
In some instances, it may be desirable to ablate perivascular renal nerves using radiofrequency energy
Implementation Method 2
Voltage may then be applied to the one or more ablation electrodes, wherein energy flows between the one or more ablation electrodes and the two or more ground pads
Implementation Method 3
Because muscle is of lower impedance than connective tissue, the propensity for generating inconsistent lesions may be greater if connective, fatty, and muscular tissues are all present
Data Source
AI summary
Systems for nerve and tissue modulation are disclosed. An example system may include an intravascular nerve modulation system including an elongated shaft having a proximal end region and a distal end region. The system may further include one or more ablation electrodes affixed to the distal end region of the elongated shaft. One or more ground pad electrodes may be provided and connected to a processor configured to modulate the impedance of each circuit completed between the ablation electrodes and the ground pads.