Renal Denervation Feedback via Evoked Neural Response
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Solution Overview
Problem
Current renal denervation procedures lack a feedback mechanism to assess the efficacy of nerve destruction, leading to inadequate delivery of destructive means and variable clinical responses due to poor probe-tissue interface and inability to monitor autonomic nerve activity near renal arteries.
Innovation Solution
A method involving a guide catheter and mapping catheter system that delivers electrical stimulation pulses to renal nerves through a stimulation electrode, with a sense electrode positioned downstream to measure neural activity, allowing for pre- and post-denervation measurements to determine the success of the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If renal denervation is performed without feedback mechanism, then procedure simplicity is maintained, but nerve destruction efficacy cannot be assessed leading to variable clinical responses
Solution Approach 1:
The patent implements a feedback mechanism by recording neural signals from the renal artery before and after denervation procedure. The system compares pre-procedure and post-procedure neural activity to determine whether nerve destruction was successful, providing real-time feedback to guide the procedure and ensure adequate nerve ablation.
Solution Approach 2:
The patent replaces empirical mechanical assessment of nerve destruction with electrical measurement of neural activity. Instead of relying on mechanical or visual assessment of tissue damage, the system uses electrical recording to objectively measure nerve function before and after the procedure, providing a more reliable assessment of denervation efficacy.
2Reliability
If empirical delivery of destructive means is used, then treatment time is reduced, but insufficient nerve fiber destruction occurs due to lack of real-time efficacy assessment
Solution Approach 1:
The system provides real-time feedback by continuously monitoring neural signals during the denervation procedure. This allows the operator to assess whether sufficient nerve fibers have been destroyed and adjust treatment parameters accordingly, ensuring complete denervation while avoiding unnecessary prolonged treatment.
Solution Approach 2:
The patent performs preliminary recording of neural activity before denervation to establish a baseline. This pre-procedure measurement allows for comparison with post-procedure signals to objectively determine whether the desired degree of nerve destruction has been achieved, guiding the completion of the procedure.
3Reliability
If no neural activity monitoring is performed, then equipment simplicity is maintained, but probe-tissue interface quality cannot be assessed leading to poor denervation outcomes
Solution Approach 1:
The patent uses neural signal recording as a feedback mechanism to assess probe-tissue interface quality. By monitoring the amplitude and characteristics of recorded neural signals, the system provides information about the quality of contact between the catheter and renal artery, allowing optimization of the denervation procedure.
Solution Approach 2:
The patent introduces neural signal recording as an intermediary measurement to assess the quality of the probe-tissue interface. Rather than directly measuring contact quality, the system uses the presence and characteristics of neural signals as an indirect indicator of proper catheter positioning and adequate tissue contact.
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
Enables precise monitoring of renal nerve activity, ensuring effective nerve destruction and improving the success rate of renal denervation procedures by providing real-time feedback on nerve integrity and lesion completeness.
Implementation Method 1
deliver one or more stimulation pulses to an aorticorenal ganglia using a stimulation electrode positioned in an abdominal aorta of the patient
Implementation Method 2
use a sense electrode positioned in the renal artery, downstream from the stimulation electrode, to sense the neural activity evoked in response to the one or more stimulation pulses
Data Source
AI summary
Techniques for evaluating neural electrical activity of renal nerves of a patient for which a renal denervation procedure has been or is going to be performed are described. A distal portion of a guide catheter is inserted through an abdominal aorta so the distal portion is positioned adjacent to a renal artery ostium, or in a proximal portion of the renal artery. The guide catheter is used to insert a distal portion of a mapping catheter within the renal artery, and a stimulation electrode positioned in the abdominal aorta (within a specified distance of the renal artery ostium) is used to deliver electrical stimulation pulse(s) to evoke a neural electrical response from renal nerves in tissue surrounding the renal artery. A sense electrode positioned in the renal artery, downstream from the stimulation electrode, is used to sense the neural electrical activity evoked in response to the stimulation pulse(s).