Expandable Bipolar Ablation Catheter for Varying Vein Diameters
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Solution Overview
Problem
Existing devices for treating chronic venous diseases like varicose veins lack the ability to deliver focused, controlled thermal energy while minimizing effects on surrounding healthy tissue, and are inefficient for veins with varying diameters.
Innovation Solution
A catheter with an inflatable balloon and bipolar electrodes that can adjust to different vein diameters, delivering radiofrequency ablative energy through anode-cathode pairs for precise treatment, and a controller to monitor impedance for contact with the vein wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a traditional unexpandable catheter is used, then the device structure is simple, but it cannot adapt to veins with varying diameters and cannot deliver focused thermal energy
Solution Approach 1:
The catheter incorporates an expandable balloon element that can transition from a collapsed state during insertion to an expanded state at the treatment site. This dynamic transformation allows the catheter to adapt to different vein diameters while maintaining a simple storage and delivery profile, resolving the contradiction between adaptability and structural simplicity.
Solution Approach 2:
The expandable balloon and electrode assemblies are nested within the catheter shaft in a collapsed configuration during insertion, then deployed outward at the target site. This nesting approach allows complex functional elements to be delivered through a simple catheter structure, enabling adaptability without permanently increasing device complexity.
2Reliability
If thermal energy is applied to treat varicose veins, then the veins can be constricted or occluded, but surrounding healthy tissue may be damaged
Solution Approach 1:
The catheter employs multiple electrode sets with selective anode-cathode pairing that can be activated independently. This allows thermal energy to be focused precisely at the electrode-tissue interface while the balloon contains the energy within the vein lumen, treating the target vein without damaging surrounding healthy tissue.
Solution Approach 2:
The inflatable balloon serves as an intermediary between the electrodes and the surrounding tissue. When inflated, it confines the thermal energy generation to the vein lumen and prevents heat transfer to adjacent healthy tissues, thereby protecting them from thermal damage while allowing effective treatment of the varicose vein.
3Use of energy by moving object
If multiple electrode sets are used for bipolar delivery, then focused thermal energy can be delivered, but the device complexity increases
Solution Approach 1:
The electrode system is divided into multiple discrete electrode sets distributed along the balloon surface, with each set containing paired anode and cathode elements. This segmentation allows selective activation of specific electrode pairs to treat different segments of the vein, providing focused thermal energy delivery while maintaining modular simplicity in the overall design.
4Area of stationary object
If the balloon is inflated to a large diameter to treat larger veins, then treatment coverage is improved, but the device may not fit smaller veins
Solution Approach 1:
The balloon is designed with dynamic expandability, allowing it to be inflated to different diameters based on the target vein size. This dynamic adjustment capability enables the same device to achieve optimal treatment coverage across a range of vein diameters, from small to large veins, without compromising adaptability.
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 catheter effectively constricts or occludes veins by adjusting to varying diameters, reducing operation time and minimizing tissue damage, while ensuring consistent thermal treatment.
Implementation Method 1
the electrodes of each electrode set are configured to form an anode-cathode pair for bipolar delivery of radiofrequency ablative energy to target tissue
Implementation Method 2
an inflatable balloon having a proximal end and an opposite distal end and defining a longitudinal dimension therebetween
Data Source
AI summary
At least some embodiments of the present disclosure are directed to a catheter for use in varicose vein treatment including a handle, an elongated shaft connected to the handle, and a heating element disposed near the distal end of the shaft. In some embodiments, the heating element includes an inflatable balloon having a proximal end and an opposite distal end and defining a longitudinal dimension therebetween, and a plurality of electrode sets including elongated electrodes extending along a majority of the longitudinal dimension of the balloon, and the electrodes of each electrode set are configured to form an anode-cathode pair for bipolar delivery of radiofrequency ablative energy to target tissue.