Helical Bipolar Electrode Renal Denervation Balloon
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Solution Overview
Problem
Current medical devices for renal nerve ablation lack effective methods for targeted and controlled energy delivery to treat conditions like hypertension without damaging neighboring nerves or tissues.
Innovation Solution
A renal nerve ablation device with an elongate tubular member, an expandable member, helically-oriented active and ground electrodes, and temperature sensors is advanced through a blood vessel, expanded, and activated to deliver energy precisely to renal nerves, allowing for controlled ablation without direct contact and minimizing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional ablation devices are used, then energy can be delivered to renal nerves, but surrounding tissues and neighboring nerves may be damaged due to lack of precise control
Solution Approach 1:
The ablation device is segmented into multiple independent electrode pairs arranged helically around the balloon circumference. Each electrode pair can be independently controlled to deliver energy to specific angular sectors, allowing precise targeting of renal nerves while avoiding adjacent tissues. The balloon itself is segmented into multiple treatable zones along its length.
Solution Approach 2:
Different regions of the balloon surface are equipped with different electrode pairs that can be selectively activated based on the specific anatomical target. The helical arrangement ensures that energy is delivered locally to the intended renal nerve region while minimizing exposure to surrounding healthy tissues. Temperature sensors are also locally positioned to monitor conditions at each electrode site.
Solution Approach 3:
Temperature sensors are integrated at each electrode pair location to provide real-time feedback on tissue temperature during ablation. This feedback enables closed-loop control of the ablation process, allowing the system to adjust energy delivery parameters to achieve effective renal nerve ablation while preventing overheating and damage to surrounding tissues. The feedback mechanism ensures precise control of the thermal field.
2Area of stationary object
If expandable balloons are used to improve contact with vessel wall, then treatment coverage is enhanced, but device complexity increases
Solution Approach 1:
The balloon is designed to be dynamically expandable from a low-profile delivery configuration to a high-profile treatment configuration. This dynamic transformation allows the device to navigate through catheters in a compressed state, then expand at the target site to maximize contact area with the vessel wall for comprehensive renal nerve treatment. The expandable nature provides adaptability without requiring a permanently complex structure.
Solution Approach 2:
The balloon and electrode assembly is designed to nest within a delivery catheter during insertion, similar to a nested doll structure. The electrodes are configured to fold or compress along with the balloon, allowing the entire treatment apparatus to pass through standard catheter delivery systems. Once deployed, the balloon expands to its full treatment configuration, providing large surface area contact without requiring a permanently large or complex delivery system.
3Productivity
If multiple electrodes are arranged to cover entire circumference, then treatment completeness is improved, but device complexity and manufacturing difficulty increase
Solution Approach 1:
Multiple electrode pairs are merged into a unified helical configuration that wraps around the balloon circumference. This merging approach allows comprehensive 360-degree coverage to be achieved through a single continuous or modular electrode structure rather than requiring separate independent electrode assemblies. The helical pattern naturally distributes electrodes around the circumference while maintaining a relatively simple overall architecture that can be manufactured as an integrated unit.
Solution Approach 2:
The electrodes are arranged in a helical (curved) pattern around the cylindrical balloon surface, following the curvature of the vessel wall when the balloon is expanded. This curved arrangement naturally adapts to the cylindrical geometry of the renal artery, ensuring uniform angular distribution of electrode pairs around the entire circumference. The helical configuration provides complete circumferential coverage while maintaining a simple, repeatable manufacturing pattern that can be produced using standard balloon fabrication techniques.
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
The device enables precise and controlled ablation of renal nerves, reducing blood pressure and associated symptoms while avoiding damage to surrounding tissues, with the ability to assess treatment efficacy and adjust parameters for optimal results.
Implementation Method 1
an expandable member coupled to the distal region, the expandable member having a length
Implementation Method 2
one or more active electrodes coupled to the expandable member... activating at least one of the one or more active electrodes
Implementation Method 3
one or more temperature sensors disposed on an outer surface of the expandable member adjacent the one or more active electrodes and the one or more ground electrodes
Data Source
AI summary
A renal nerve ablation device may include an elongate tubular member having a distal region. An expandable member may be coupled to the distal region. One or more active electrodes may be coupled to the expandable member. One or more ground electrodes may be coupled to the expandable member. The one or more active electrodes and/or the one or more ground electrodes may be oriented helically about the length of the expandable member.