Renal Neuromodulation Biomarker Feedback for Real-Time Efficacy
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Solution Overview
Problem
Current methods for evaluating the efficacy of renal neuromodulation procedures, such as renal denervation, lack real-time or contemporaneous feedback, often leading to under-ablation or over-ablation due to the delayed observation of statistically meaningful changes in blood pressure, which can occur weeks or months after the procedure.
Innovation Solution
Monitoring neuromodulation efficacy by detecting changes in the level or activity of one or more target biomarkers, such as proteins or small molecules, using methods and devices that allow for real-time or relatively contemporaneous assessment of nerve ablation success, including the use of biomarker detection systems and kits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional blood pressure monitoring methods are used to evaluate neuromodulation efficacy, then measurement reliability is improved, but time delay increases significantly (weeks or months)
Solution Approach 1:
The patent implements real-time feedback by detecting biomarkers (such as norepinephrine levels) that directly indicate neuromodulation efficacy. This allows immediate adjustment of treatment parameters during the procedure, eliminating the weeks-or-months delay inherent in traditional blood pressure monitoring while maintaining measurement reliability through validated biomarker assays.
Solution Approach 2:
The patent introduces biomarkers as intermediary indicators that correlate with neuromodulation efficacy. These biomarkers serve as mediators between the neuromodulation procedure and the final outcome measurement, providing timely information that reflects treatment effectiveness without requiring waiting for blood pressure changes to manifest.
2Loss of time
If real-time biomarker detection is implemented, then time delay is reduced, but device complexity increases
Solution Approach 1:
The patent extracts the detection function from the neuromodulation system by using separate biomarker detection assays performed on blood samples. This modular approach allows real-time monitoring capability to be added without fundamentally redesigning the entire neuromodulation device, thereby limiting the increase in overall system complexity.
Solution Approach 2:
The patent uses biomarker levels as a copy or proxy for the actual neuromodulation efficacy. Instead of directly measuring complex neural effects in real-time, the system measures biomarker concentrations that reflect treatment outcomes, providing a simplified real-time indicator that avoids the need for highly complex direct neural monitoring equipment.
3Manufacturing precision
If precise nerve ablation is achieved through real-time monitoring, then manufacturing precision is improved, but measurement difficulty increases
Solution Approach 1:
The patent replaces direct mechanical or electrical measurement of nerve ablation with biochemical measurement of biomarkers. This substitution transforms the measurement challenge from detecting complex electrical neural signals to measuring chemical concentrations, which can be done with standardized laboratory techniques, thereby managing measurement difficulty while improving ablation precision.
Data Source
AI summary
Provided herein are methods, devices, compositions, and kits for monitoring neuromodulation efficacy based on changes in the level or activity of one or more target biomarkers. A method can include transluminally delivering a distal portion of an elongated shaft of a catheter to a target renal blood vessel and at least partially inhibiting sympathetic neural activity of a renal nerve. The method includes determining a post-neuromodulation level of one or more biomarkers after at least partially inhibiting the sympathetic neural activity of the renal nerve, wherein the level of the one or more biomarkers directly or indirectly correlates with sympathetic nervous activity in the patient. The method can include comparing the post-neuromodulation level to a predetermined level for the one or more biomarkers, wherein the renal neuromodulation procedure is classified as at least partially successful if the post-neuromodulation level differs from the predetermined level.