Renal Denervation Balloon Catheter Feedback System
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Solution Overview
Problem
Current renal denervation procedures lack effective feedback mechanisms to assess the efficacy of the treatment during the procedure, making it difficult for operators to determine if additional power, duration, or ablation locations are needed to achieve adequate renal denervation.
Innovation Solution
A renal denervation system that includes a renal ablation catheter and an inflatable balloon within the renal artery, where blood pressure conditions and balloon performance characteristics are measured before and after ablation to assess the efficacy of the procedure, using blood pressure decay and inflation time as indicators of sympathetic tone reduction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If renal denervation is performed using radiofrequency ablation catheter, then sympathetic nerve activity is blocked to treat hypertension, but there is no feedback mechanism to assess treatment efficacy during the procedure
Solution Approach 1:
The patent implements a feedback mechanism by measuring blood pressure conditions before and after renal denervation ablation. The system compares pre-ablation and post-ablation blood pressure measurements to determine whether the ablation achieved the desired sympathetic nerve blockade, providing operators with intraoperative feedback on treatment efficacy without requiring additional complex sensing devices beyond standard blood pressure monitoring.
2Reliability
If additional power and duration are applied to achieve adequate renal denervation, then treatment efficacy improves, but treatment time and energy consumption increase
Solution Approach 1:
By providing real-time feedback on ablation efficacy through blood pressure measurements, operators can determine the optimal point at which adequate denervation has been achieved. This allows for precise control of ablation parameters, preventing both under-treatment (which would require repeat procedures) and over-treatment (which would waste time and energy), thereby optimizing the balance between treatment efficacy and procedure duration.
3Reliability
If multiple ablation locations are treated to ensure adequate renal denervation, then treatment coverage improves, but procedure complexity and time increase
Solution Approach 1:
The blood pressure feedback mechanism allows operators to assess the cumulative effect of ablation at different locations systematically. By measuring blood pressure changes after each ablation site treatment, operators can determine whether additional locations require ablation or whether the desired sympathetic blockade has been achieved, thereby reducing unnecessary ablation sites and simplifying the overall procedure while ensuring adequate coverage.
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
Provides real-time feedback to operators on the efficacy of renal denervation, allowing for adjustments during the procedure to ensure minimal and effective treatment, thereby improving the precision and effectiveness of renal denervation.
Implementation Method 1
The inflated balloon may block blood flow through the renal artery temporarily
Implementation Method 2
the blood pressure condition is assessed at a location distal of the inflation balloon (e.g., between the inflation balloon and the kidney) with a blood pressure measurement sensor
Implementation Method 3
A conventional renal denervation procedure involves introducing a radiofrequency (RF) ablation catheter, which ablates renal nerves at various locations using variable energy
Implementation Method 4
The blood pressure condition assessment includes a rate of decay of the blood pressure after blood occlusion due to balloon inflation
Implementation Method 5
Another blood pressure condition assessment includes a time period required to inflate the inflation balloon. The time period required to inflate the balloon to reach a pressure threshold may relate to the degree of vasodilation in the renal artery
Data Source
AI summary
A renal denervation system includes an ablation catheter and an inflation balloon. The renal denervation catheter is insertable into a renal artery to perform a renal denervation procedure. The inflation balloon is inflatable within the renal artery, wherein one of a blood pressure condition in the renal artery resulting from operation of the inflation balloon and a performance characteristic of the inflation balloon indicates efficacy of the renal denervation procedure.