Renal Denervation Catheter with Vibration Sensor for Real-Time Efficacy Assessment
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Solution Overview
Problem
Current renal denervation procedures lack real-time feedback mechanisms to determine the efficacy of nerve ablation during the procedure, making it difficult for operators to assess whether sufficient energy has been applied at appropriate locations to achieve effective denervation.
Innovation Solution
A renal denervation catheter equipped with a vibration sensor or a temperature monitoring system to measure changes in blood flow rate before and after ablation, providing real-time feedback on the efficacy of the procedure by correlating these changes with the effectiveness of nerve ablation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If renal denervation is performed using RF ablation catheter, then sympathetic activities are suppressed and blood pressure is reduced, but there is no real-time feedback mechanism to assess the efficacy of the procedure
Solution Approach 1:
The patent implements a feedback mechanism by measuring vibrations in the renal denervation catheter before and after ablation. The vibration sensor detects changes in catheter vibrations that correlate with blood flow rate changes, providing real-time information to the operator about the efficacy of the denervation procedure. This allows the operator to assess whether additional ablation is needed based on quantitative feedback.
2Loss of information
If vibration sensor is added to the catheter, then real-time feedback on blood flow rate changes is obtained, but device complexity increases
Solution Approach 1:
The vibration sensor serves multiple functions: it monitors catheter position, detects blood flow rate changes through vibration analysis, and provides feedback on ablation efficacy. By making the sensor multi-functional, the patent reduces the need for separate specialized components, thereby limiting the increase in device complexity while still providing the necessary feedback information.
3Reliability
If multiple ablation locations are applied to ensure adequate denervation, then efficacy is improved, but energy consumption and procedure time increase
Solution Approach 1:
The vibration-based feedback system allows the operator to assess denervation efficacy at each ablation location in real-time. By measuring changes in catheter vibrations that correlate with blood flow rate changes, the operator can determine whether the current ablation location and energy level were sufficient before proceeding to the next location. This prevents unnecessary additional ablation and optimizes energy usage.
4Reliability
If ablation energy is increased to ensure adequate nerve destruction, then denervation efficacy is improved, but risk of harmful effects increases
Solution Approach 1:
The real-time vibration monitoring provides feedback on the physiological response to ablation, allowing the operator to titrate the ablation energy to the minimum level needed to achieve adequate denervation. By assessing blood flow rate changes through vibration analysis after each ablation pulse, the operator can avoid excessive energy application that could cause harmful effects to surrounding tissues.
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 operators to assess the success of renal denervation in real-time, ensuring adequate nerve ablation and minimizing unnecessary energy application, thereby improving the procedure's effectiveness and safety.
Implementation Method 1
The vibration sensor is configured to measure vibrations in the renal denervation catheter prior to and after operating the at least one ablation member to ablate the renal nerves
Implementation Method 2
An established renal denervation procedure involves introducing a radiofrequency (RF) ablation catheter, which ablates renal nerves at various locations using variable energy
Implementation Method 3
The at least one ablation member may include one of an ultrasound member and a radio frequency member
Implementation Method 4
The temperature monitoring system may include a fluid outlet to deliver a flow of fluid into the blood flow, and the at least one temperature sensor may be positioned downstream of the fluid outlet
Data Source
AI summary
A renal denervation catheter includes a catheter shaft, at least one ablation member, and a sensor, and is operable to perform a renal denervation procedure. The catheter shaft includes a distal end portion insertable into a renal artery. The at least one ablation member is positioned at the distal end portion of the catheter shaft and operable to ablate renal nerves along a wall of the renal artery. The sensor provides information that correlates to blood flow in the renal artery. A change in blood flow rate in the renal artery resulting from the ablation is indicative of the efficacy of the renal denervation procedure.