Catheter Flow Sensor for Renal Denervation Monitoring
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Solution Overview
Problem
Current renal denervation procedures lack effective sensing capabilities to verify the outcome of ablation, limiting their applicability due to the absence of real-time monitoring of tissue state changes in renal arteries and other tissues during and after procedures.
Innovation Solution
Development of catheter devices equipped with integrated circuitry, flow sensors, and expandable bodies that include pacing and radiofrequency electrodes, temperature sensors, and assessment modules to measure and provide feedback on renal blood flow, enabling real-time monitoring and verification of ablation efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If renal denervation procedures are performed without integrated sensing capabilities, then the procedure can be performed with simpler device architecture, but the ability to verify ablation outcome and monitor tissue state changes is insufficient
Solution Approach 1:
The patent combines multiple functions (ablation, sensing, monitoring) into a single integrated catheter device. The catheter includes both radiofrequency electrodes for ablation and flow sensors for monitoring, eliminating the need for separate verification procedures and enabling real-time assessment of ablation efficacy within the same device platform
Solution Approach 2:
The patent implements real-time feedback through flow sensors that monitor renal blood flow changes during and after ablation. The assessment module processes flow measurements to provide immediate feedback on ablation efficacy, allowing the physician to verify the outcome and adjust the procedure accordingly, thereby improving reliability without requiring complex post-procedure verification
2Ease of operation
If real-time monitoring of tissue state changes is implemented, then the applicability and safety of the procedure is improved, but the device complexity and cost increases
Solution Approach 1:
The catheter device is designed with multi-functionality, serving as both an ablation device and a monitoring device. The same catheter structure delivers radiofrequency energy and simultaneously measures flow parameters, eliminating the need for separate monitoring equipment and reducing overall system complexity despite the enhanced capabilities
Solution Approach 2:
The catheter performs self-monitoring through integrated flow sensors that automatically measure renal blood flow changes during the procedure. The assessment module processes this data to provide real-time information on tissue state changes, enabling the device to monitor its own performance and the physiological response without requiring external monitoring systems
3Measurement precision
If flow sensors and assessment modules are integrated into the catheter, then the precision of measuring renal blood flow changes is improved, but the manufacturing complexity increases
Solution Approach 1:
The catheter is designed with modular segmentation, where flow sensors, electrodes, and the assessment module are distinct functional units that can be independently manufactured and then assembled. This modular approach allows each component to be optimized and manufactured separately using appropriate processes, then integrated into the final catheter assembly, reducing overall manufacturing complexity
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 blood flow changes before and after procedures, providing a credible clinical endpoint for renal sympathetic denervation and facilitating more effective and safe treatment by ensuring the success of the denervation process.
Implementation Method 1
a heating element, and a temperature sensor disposed proximate to the heating element, where measurement of the temperature sensor provides an indication of a flow rate of blood
Data Source
AI summary
Devices and methods are provided for performing an ablation procedure on tissue with flow monitoring using flow sensors. The devices include a catheter, and at least one flow sensor disposed on the catheter, and a component for applying the ablation procedure. An assessment module provides an indication of the efficacy of the ablation procedure based on the flow measurement from the flow sensor.