Controlled Sympathectomy Catheter With Electrophysiological Feedback
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Solution Overview
Problem
Current methodologies for denervation, such as renal sympathetic nerve ablation, lack adequate feedback regarding the site of denervation, extent of denervation, and effect on local physiology, leading to ineffective modulation of sympathetic activity in conditions like hypertension and diabetes.
Innovation Solution
A microsurgical tool with a microfinger and sensing tip is used to monitor electrophysiological activity within a lumen, providing real-time feedback for controlled neuromodulation through electrophysiological signal monitoring and ablation, including mechanisms like radio frequency ablation and ultrasonic ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional denervation methodologies are used, then sympathetic nerve ablation can be performed, but adequate feedback regarding site of denervation, extent of denervation, and effect on local physiology is not provided
Solution Approach 1:
The patent incorporates electrophysiological sensing tips that continuously monitor nerve activity during and after ablation procedures. These sensing tips provide real-time feedback signals about the site of denervation, extent of denervation, and effects on local physiology, enabling the operator to adjust the ablation parameters to achieve the desired outcome while avoiding excessive or insufficient treatment.
Solution Approach 2:
The patent replaces purely mechanical ablation methods with an integrated system that combines mechanical ablation (RF or ultrasonic energy delivery) with electrophysiological sensing. The sensing tips detect electrical signals from the nerve tissue, providing feedback about nerve integrity and ablation effectiveness, thereby replacing blind mechanical ablation with a feedback-guided approach.
2Measurement precision
If microfinger is biased against lumen wall to maintain contact, then electrophysiological signals can be monitored, but the microfinger may damage the lumen wall
Solution Approach 1:
The patent applies partial action by using a microfinger with controlled bias force that is sufficient to maintain contact with the lumen wall for signal monitoring but not excessive enough to cause damage. The bias force is optimized to achieve the minimum necessary contact for electrophysiological signal acquisition, avoiding unnecessary mechanical stress on the lumen wall tissue.
Solution Approach 2:
The sensing tip acts as an intermediary between the microfinger and the lumen wall. Instead of the microfinger directly damaging the tissue, the sensing tip with its delicate electrode structure makes contact with the lumen wall to pick up electrophysiological signals, while the microfinger provides only gentle bias force to maintain this contact without causing mechanical injury.
3Reliability
If ablation energy is applied to achieve sufficient denervation, then sympathetic activity can be modulated, but surrounding anatomy may be damaged
Solution Approach 1:
The patent uses electrophysiological feedback signals from the sensing tips to monitor nerve integrity in real-time during ablation. When the sensing tips detect that the nerve is sufficiently denervated, the system can stop energy delivery, preventing excessive ablation that would damage surrounding anatomy. The feedback enables precise control of ablation energy to achieve the minimum effective dose.
Solution Approach 2:
The patent employs periodic or pulsed ablation energy delivery rather than continuous energy application. The ablation energy is applied in controlled pulses, allowing the surrounding anatomy to recover between pulses and preventing cumulative damage. This periodic action enables sufficient denervation of the target nerve while minimizing harm to adjacent structures.
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 and modulation of sympathetic tone, allowing for controlled neuromodulation with reduced impact on surrounding anatomy, effectively addressing conditions like hypertension and diabetes by ensuring adequate denervation.
Implementation Method 1
a sensing tip electrically and mechanically coupled to the microfinger in the vicinity of the region, configured to interface with the wall of the lumen, the sensing tip configured to convey one or more electrophysiological signals associated with the activity
Implementation Method 2
mechanisms like radio frequency ablation
Implementation Method 3
mechanisms like radio frequency ablation and ultrasonic ablation
Data Source
AI summary
A catheter system for controlled sympathectomy procedures is disclosed. A catheter system for controlled micro ablation procedures is disclosed. Methods for performing a controlled surgical procedure are disclosed. A system for performing controlled surgical procedures in a minimally invasive manner is disclosed.