Intravascular Neuromodulation Balloon for Renal Nerve Targeting
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Solution Overview
Problem
Intravascular pulsed electric field systems face challenges in selectively electroporating target renal nerve cells without damaging smooth muscle cells, requiring high voltage that can cause persistent injury to non-target tissue, making it difficult to achieve desired renal neuromodulation without concomitant damage.
Innovation Solution
The use of a catheter with bipolar electrodes and an impedance-altering element, such as an inflatable balloon, to locally increase impedance within the vasculature, reducing the required voltage for neuromodulation by aligning the electric field with the lengthwise dimension of renal nerves and propagating it along the longitudinal axis, thereby minimizing effects on smooth muscle cells.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high voltage is applied to electroporate renal nerve cells, then neuromodulation effectiveness is improved, but damage to smooth muscle cells increases
Solution Approach 1:
The patent applies local quality by creating a non-uniform electric field distribution through the impedance-altering element (balloon). The element concentrates the electric field locally at the renal nerve location while limiting field penetration into surrounding tissues. This allows effective electroporation of target nerves without exposing smooth muscle cells to damaging voltage levels, as the field strength decreases with distance from the concentrated zone.
Solution Approach 2:
The impedance-altering element (balloon) serves as an intermediary between the electrode and the tissues. It modifies the electric field distribution by its impedance properties, acting as a mediator that directs and confines the field to the desired target area. The balloon's dielectric properties create field concentration at the nerve interface while providing electrical isolation that protects adjacent smooth muscle cells from direct field exposure.
2Reliability
If high voltage is applied to achieve renal neuromodulation, then treatment effectiveness is improved, but persistent injury to non-target tissue occurs
Solution Approach 1:
By concentrating the electric field locally at the renal nerve interface through the impedance-altering element, the treatment achieves effective neuromodulation in the target zone while minimizing field exposure to non-target tissues. The localized field confinement ensures that only the intended nerves receive sufficient voltage for electroporation, preventing persistent injury to surrounding healthy tissues through reduced off-target exposure.
Solution Approach 2:
The patent applies partial action by delivering electric field energy selectively to only the portion of tissue containing renal nerves, rather than uniformly exposing all surrounding tissues. The impedance-altering element enables this selective partial exposure, concentrating energy where needed for effective treatment while leaving other areas below the threshold for damaging effects, thus avoiding persistent injury.
3Device complexity
If electric field is applied without impedance alteration, then system simplicity is maintained, but voltage required for neuromodulation increases
Solution Approach 1:
The impedance-altering element functions as an intermediary that modifies the electrical characteristics of the treatment interface. By introducing this element between the electrode and tissues, the system achieves better field confinement and targeting efficiency. This intermediary improves the coupling between the applied voltage and the target nerves, reducing the overall voltage magnitude needed to achieve effective electroporation compared to direct electrode-to-tissue application.
Solution Approach 2:
The patent changes the electrical impedance parameter at the treatment site by deploying the impedance-altering element. This parameter change creates a more favorable electrical environment for field concentration, allowing the system to achieve the same neuromodulation effect at lower voltage levels. The element's dielectric properties modify the field distribution parameters, improving energy efficiency and reducing the stress (voltage) required for effective treatment.
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 reduces the necessary applied voltage for neuromodulation, minimizing damage to non-target tissue and achieving effective renal denervation while maintaining the integrity of the vessel wall, thus alleviating symptoms of congestive heart failure and renal diseases.
Implementation Method 1
an impedance-altering element, such as an inflatable balloon, to locally increase impedance within the vasculature, reducing the required voltage for neuromodulation by aligning the electric field with the lengthwise dimension of renal nerves
Implementation Method 2
The use of a catheter with bipolar electrodes and an impedance-altering element, such as an inflatable balloon, to locally increase impedance within the vasculature, reducing the required voltage for neuromodulation by aligning the electric field with the lengthwise dimension of renal nerves and propagating it along the longitudinal axis
Data Source
AI summary
Methods and apparatus are provided for intravascularly-induced neuromodulation using a pulsed electric field, e.g., to effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, changes in cytokine upregulation, etc., in target neural fibers. In some embodiments, the intravascular PEF system comprises a catheter having a pair of bipolar electrodes for delivering the PEF, with a first electrode positioned on a first side of an impedance-altering element and a second electrode positioned on an opposing side of the impedance-altering element. A length of the electrodes, as well as a separation distance between the first and second electrodes, may be specified such that, with the impedance-altering element deployed in a manner that locally increases impedance within a patient's vessel, e.g., with the impedance-altering element deployed into contact with the vessel wall at a treatment site within the patient's vasculature, a magnitude of applied voltage delivered across the bipolar electrodes necessary to achieve desired neuromodulation is reduced relative to an intravascular PEF system having similarly spaced electrodes but no (or an undeployed) impedance-altering element. In a preferred embodiment, the impedance-altering element comprises an inflatable balloon configured to locally increase impedance within a patient's vasculature. The methods and apparatus of the present invention may be used to modulate a neural fiber that contributes to renal function.