Bilateral Renal Neuromodulation via Bidirectional Pulsed Electric Fields
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Solution Overview
Problem
Current intravascular pulsed electric field systems for treating renal disorders face challenges in selectively electroporating target cells without damaging smooth muscle cells, leading to inadequate renal neuromodulation and potential vascular injury.
Innovation Solution
The use of a pulsed electric field with aligned electric field propagation along the longitudinal dimension of renal arteries to preferentially affect renal nerves while minimizing impact on smooth muscle cells, combined with monitoring techniques to adjust and control electroporation parameters, allowing for bilateral renal neuromodulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a pulsed electric field is applied to renal arteries for neuromodulation, then renal nerve activity is reduced, but smooth muscle cells may be damaged causing vascular injury
Solution Approach 1:
The patent applies different electric field strengths at different locations: a higher strength pulsed electric field is applied specifically to the renal nerves within the vessel wall for neuromodulation, while a lower strength field is applied to the surrounding vascular tissue to prevent damage. This spatial differentiation of field intensity achieves selective nerve targeting without harming the vessel structure.
Solution Approach 2:
The patent utilizes bidirectional electric field parameter modulation, applying positive polarity pulses for neuromodulation followed by negative polarity pulses for protection. This parameter switching allows the system to achieve therapeutic effects during the positive phase while preventing tissue damage during the negative phase, resolving the contradiction between treatment efficacy and safety.
2Manufacturing precision
If electric field strength is increased to ensure complete renal nerve electroporation, then neuromodulation effectiveness improves, but risk of damaging non-target cells increases
Solution Approach 1:
The patent employs periodic bidirectional pulsed electric fields with alternating positive and negative polarity. The positive pulses deliver sufficient field strength for complete renal nerve electroporation and neuromodulation, while the subsequent negative pulses reduce field strength to protect non-target cells. This periodic switching allows achievement of complete electroporation without sustained high-field exposure that would cause collateral damage.
Solution Approach 2:
The patent applies protective negative polarity pulses following the therapeutic positive pulses as a preliminary protective measure. This preliminary action prepares the tissue for potential subsequent treatments while preventing accumulation of thermal and electrical stress that could lead to non-target cell damage, thereby enabling repeated high-strength treatment pulses.
3Reliability
If bilateral renal neuromodulation is performed simultaneously, then therapeutic effect is enhanced, but system complexity and procedure time increase
Solution Approach 1:
The patent combines bilateral renal neuromodulation into a single integrated procedure by positioning electrodes on both renal arteries and applying coordinated bidirectional pulsed electric fields simultaneously or in rapid sequence. This merging of bilateral treatments into one procedural framework enhances therapeutic effect through comprehensive nerve modulation while avoiding the need for separate surgical interventions, thereby managing system complexity efficiently.
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 enables effective bilateral renal neuromodulation, reducing the risk of vascular damage and achieving desired therapeutic effects such as increased urine output, decreased plasma renin levels, and controlled blood pressure, potentially preventing or treating conditions like congestive heart failure and hypertension.
Implementation Method 1
A pulsed electric field may initiate renal neuromodulation, e.g., denervation, for example, via irreversible electroporation or via electrofusion
Data Source
AI summary
Methods and apparatus are provided for treating hypertension, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such 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, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.