Compliant Balloon Renal Nerve Ablation Device
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Solution Overview
Problem
Current medical devices for renal nerve ablation face challenges in achieving precise energy delivery and avoiding damage to neighboring tissues, particularly due to the mal-apposition of non-compliant balloons in tapered blood vessels, which can lead to stress-induced trauma.
Innovation Solution
The development of renal nerve ablation devices with compliant balloons and flexible circuit assemblies, including bipolar electrodes and sensors, that allow for controlled energy delivery and inflation pressure management to ensure precise contact and minimize trauma, using materials like Pebax and polyurethane for the balloon and electrodes, and polytetrafluoroethylene for the catheter shaft.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If non-compliant balloons are used for renal nerve ablation, then structural stability is improved, but vessel trauma increases due to mal-apposition in tapered blood vessels
Solution Approach 1:
The patent employs a compliant balloon made from flexible materials such as Pebax and polyurethane that can conform to the vessel wall geometry. This flexible shell approach allows the balloon to adapt to tapered blood vessel shapes without causing stress-induced trauma, while still providing stable apposition for precise energy delivery during renal nerve ablation.
2Object-affected harmful factors
If balloon compliance is increased to reduce vessel trauma, then vessel trauma decreases, but energy delivery precision may be compromised
Solution Approach 1:
The patent utilizes temperature sensors and pressure sensors to monitor and control physical parameters during the ablation procedure. Real-time feedback from these sensors allows dynamic adjustment of energy delivery parameters, ensuring precise energy deposition while maintaining balloon compliance to prevent vessel trauma.
3Manufacturing precision
If rigid structures are used for energy delivery, then energy delivery precision is improved, but adaptability to vessel geometry decreases
Solution Approach 1:
The patent employs a dynamically adaptable balloon structure that can change its shape and conform to the vessel wall. This dynamic compliance allows the device to maintain precise energy delivery capability while adapting to various vessel geometries, including tapered configurations, without requiring rigid structural components.
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 and controlled renal nerve ablation with reduced risk of vessel trauma by allowing the balloon to conform to the vessel shape and providing real-time temperature and pressure feedback for optimal energy delivery and apposition.
Implementation Method 1
compliant balloon coupled to the distal region
Implementation Method 2
one or more pressure sensors that are each coupled to the compliant balloon
Implementation Method 3
one or more temperature sensors and one or more pressure sensors that are each coupled to the compliant balloon
Implementation Method 4
one or more pairs of bipolar electrodes coupled to the compliant balloon
Data Source
AI summary
Medical devices for renal nerve ablation are disclosed. An example medical device for renal nerve ablation may include a catheter shaft having a distal region. The device may include an expandable member coupled to the distal region, a flexible circuit assembly coupled to the expandable member, and a pressure sensor disposed along the expandable member and positioned adjacent to the flexible circuit assembly. The flexible circuit assembly may include one or more pairs of bipolar electrodes and a temperature sensor.