Cool-tip Electrode Introducer for Large Ablation Volumes
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Solution Overview
Problem
Current radiofrequency electrode systems for tissue ablation are limited in producing large enough lesion volumes to effectively treat large cancerous tumors, requiring multiple electrode insertions and complex planning for heat distribution.
Innovation Solution
A cluster electrode system with a hub and at least three electrodes, each with a sealed conductive tip and closed-loop fluid communication channel for coolant, along with an introducer that orients and spaces the electrodes for coherent heat ablation, allowing simultaneous application of high-frequency voltage to generate large heat ablation volumes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of stationary object
If multiple electrodes are inserted into the body in an array to enlarge ablation volumes, then the ablation volume is improved, but the device complexity and difficulty of placement increase
Solution Approach 1:
Multiple electrode shafts are combined into a single introducer assembly with a common hub and coordinated insertion mechanism. The introducer includes multiple holes arranged in specific patterns that receive multiple electrodes, allowing them to be inserted simultaneously as a unified structure rather than separately, thereby reducing procedural complexity while achieving large ablation volumes
Solution Approach 2:
The introducer is pre-configured with holes positioned at predetermined locations and orientations before insertion. This preliminary arrangement of holes ensures that when electrodes are inserted through the introducer, they are automatically positioned in the correct spatial relationship to create the desired ablation volume, eliminating the need for complex real-time positioning adjustments
2Stability of the object's composition
If electrodes are placed in a dispersed fashion throughout the tumor volume, then heat distribution uniformity is improved, but the number of tissue insertions and planning complexity increase
Solution Approach 1:
The introducer is divided into multiple functional components: a hub portion with multiple holes arranged in specific patterns, a shaft portion with corresponding hole alignments, and distal and proximal sections with coordinated hole configurations. This segmentation allows each component to be optimized for specific electrode positioning requirements while maintaining overall simplicity of operation
Solution Approach 2:
The introducer acts as an intermediary device between the operator and the electrode array. It provides a pre-formed template with holes that guide electrode placement, translating the operator's simple insertion action into the complex task of positioning multiple electrodes in precise dispersed arrangements throughout the tumor volume
3Volume of stationary object
If cooled conductive tips are used, then lesion volume is improved, but the device complexity increases
Solution Approach 1:
The cooling channel is nested within the electrode shaft structure. The shaft includes an insulating portion and a conductive tip portion, with cooling channels integrated into the shaft body that are positioned to thermally couple with the conductive tip. This nested configuration allows cooling functionality to be incorporated without significantly increasing external device dimensions or overall complexity
Solution Approach 2:
A cooling fluid is circulated through channels in the shaft to cool the conductive tip portion of the electrode. The cooling system uses fluid dynamics (hydraulic cooling) to remove heat from the electrode tip, enabling the generation of larger lesion volumes by preventing overheating and allowing sustained high-power RF delivery
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 system enables the creation of larger heat ablation volumes, reducing the number of tissue insertions and facilitating simpler planning for effective tumor treatment with minimal patient discomfort and risk of hemorrhage.
Implementation Method 1
Each electrode further includes a closed-loop fluid communication channel pathway which includes an inflow opening adapted for connection to a coolant fluid supply, and a channel portion in fluid communication with the inflow opening. The channel portion extends distally inside the conductive tip portion to carry coolant to the inside of the conductive tip portion
Implementation Method 2
The electrode is connected to a radiofrequency power source, which provides radiofrequency voltage to the electrode, which transmits the radiofrequency current into the tissue near its exposed conductive tip
Implementation Method 3
The electrode system includes a hub; and at least three electrodes... adapted to simultaneously apply an equal output voltage to each of the exposed conductive tip portions... to induce coherent high frequency heat ablation volumes within targeted tissue
Data Source
AI summary
The present disclosure relates to systems, devices and methods for positioning and placing multiple electrodes in a target surgical site. An introducer is provided for facilitating the insertion of a cluster of electrodes into the body of a patient for performing tissue ablation. The introducer includes a body portion including a plurality of holes formed therein for selectively receiving a respective elongate shaft of the electrodes therethrough, wherein the holes of the introducer orient and space each electrode relative to one another, wherein the introducer includes a centrally disposed hole formed therein for receiving a guide needle therethrough.