Monopolar PEF Renal Neuromodulation Selective Nerve Ablation
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Solution Overview
Problem
Current methods for intravascular pulsed electric field (PEF) systems in treating renal disorders face challenges in selectively electroporating target cells without damaging smooth muscle cells, leading to either persistent injury to the renal vasculature or inadequate renal neuromodulation.
Innovation Solution
The use of monopolar PEF systems that align the electric field with the lengthwise dimension of renal nerves, reducing the energy required for irreversible electroporation while minimizing effects on smooth muscle cells, combined with monitoring tissue impedance to control and adjust the electroporation process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high energy PEF is applied to achieve irreversible electroporation of renal nerves, then renal neuromodulation is achieved, but smooth muscle cells are damaged causing persistent vascular injury
Solution Approach 1:
The patent applies local quality by creating non-uniform electric field distribution through bipolar electrode configuration, where the electric field intensity is locally concentrated at the electrode tips facing each other across the vessel wall. This allows selective electroporation of renal nerves in the high-field region while sparing smooth muscle cells in low-field regions, thus achieving renal neuromodulation without persistent vascular damage
Solution Approach 2:
The patent employs dynamic control of PEF delivery parameters including adjustable pulse amplitude, pulse width, and number of pulses. The system dynamically adapts the electric field strength and duration to achieve irreversible electroporation of renal nerves while maintaining field strength below the threshold for smooth muscle cell damage, resolving the contradiction between treatment efficacy and vascular safety
2Object-affected harmful factors
If low energy PEF is applied to minimize vascular damage, then smooth muscle cells are preserved, but inadequate renal neuromodulation is achieved
Solution Approach 1:
The bipolar electrode configuration creates a localized high-intensity electric field region between the opposing electrode tips, concentrating the energy delivery precisely where renal nerves are located. This allows use of lower overall energy levels that minimize vascular damage while achieving sufficient field strength locally for effective renal neuromodulation
Solution Approach 2:
The patent segments the electric field delivery into multiple controlled pulses with adjustable parameters. By delivering energy in segmented pulses rather than a single high-energy burst, the system accumulates the electroporative effect on renal nerves while keeping instantaneous power levels below the threshold for smooth muscle cell damage
3Use of energy by moving object
If monopolar PEF is used to reduce energy requirements, then electroporation efficiency increases, but selective targeting becomes difficult
Solution Approach 1:
The bipolar electrode configuration creates a highly localized electric field region between the opposing electrodes, concentrating the monopolar PEF energy precisely where renal nerves are located in the vessel wall. This spatial concentration maintains high electroporation efficiency while inherently providing selective targeting by limiting the high-field region to the immediate vicinity of the electrode tips
Solution Approach 2:
The patent uses the vessel wall itself as an intermediary medium that guides and shapes the electric field. The bipolar electrodes are positioned on opposite sides of the vessel, using the vessel wall tissue as the medium through which the electric field passes, thereby concentrating energy at the nerve-rich regions while the field naturally decays with distance, providing selective targeting
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 effectively achieves renal neuromodulation by preferentially affecting renal nerve cells, reducing the risk of vascular damage and enhancing therapeutic outcomes for conditions like congestive heart failure and hypertension, with potential long-term benefits and reduced need for repeated treatments.
Implementation Method 1
A pulsed electric field may initiate renal neuromodulation, e.g., denervation, for example, via irreversible electroporation
Implementation Method 2
The porosity of a cell membrane may be increased by inducing a sufficient voltage across the cell membrane through, e.g., short, high-voltage pulses
Implementation Method 3
monitoring the impedance or conductivity of target and/or non-target tissue may be utilized to determine the onset of electroporation
Data Source
AI summary
Methods and apparatus are provided for monopolar neuromodulation, e.g., via a pulsed electric field. Such monopolar neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, monopolar neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such monopolar neuromodulation is performed bilaterally.