Electrode Array for Spherical Tissue Ablation
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Solution Overview
Problem
Current mono-polar radio frequency (RF) devices for tissue ablation are complex, difficult to use, and result in uneven heating and tumor seeding due to their limited scope and size of ablation, leading to inefficiencies and auxiliary injuries.
Innovation Solution
A tissue ablation system with a hand piece, deployment slider, delivery member/tube, and plurality of energy conduits that deploy to encircle the target tissue, allowing for controlled energy delivery and uniform ablation through radio frequency energy, using materials like nickel titanium alloys and varying diameters to manage energy density and spacing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If mono-polar RF devices are used for tissue ablation, then tissue ablation can be performed, but the heating is uneven and tumor seeding occurs due to limited scope and size of ablation
Solution Approach 1:
The ablation device is divided into multiple independent electrodes (typically 4-8 electrodes) arranged around the target tissue. Each electrode can be independently controlled and positioned, allowing segmented delivery of RF energy from multiple directions simultaneously. This segmentation enables uniform heating throughout the target tissue volume while avoiding the uneven heating and tumor seeding problems associated with single-point penetration methods.
Solution Approach 2:
The invention transitions from one-dimensional (single-point) penetration ablation to three-dimensional encirclement ablation. Multiple electrodes are positioned around the target tissue in a circumferential arrangement, delivering RF energy from all directions simultaneously. This dimensional change creates a spherical or ellipsoidal ablation zone that uniformly encompasses the target tissue, eliminating the need for repeated penetrations that cause tumor seeding.
2Manufacturing precision
If multiple penetration and retraction operations are performed, then ablation can be achieved, but auxiliary injury occurs through grounding pad burns and tumor seeding
Solution Approach 1:
Multiple electrode functions are merged into a single device that can encircle the target tissue. The device combines multiple RF energy delivery pathways, grounding connections, and deployment mechanisms into one integrated system. This merging allows simultaneous multi-directional ablation in a single procedure, eliminating the need for repeated penetrations and grounding pad applications that cause auxiliary injuries.
Solution Approach 2:
The device introduces an intermediary encircling structure (the electrode array) between the RF energy source and the target tissue. This intermediary structure distributes the RF energy uniformly around the target tissue and provides a controlled return path for current, eliminating the need for external grounding pads that cause burns. The intermediary structure also prevents direct repeated penetration of the tissue, avoiding tumor seeding.
3Device complexity
If mono-polar devices with limited scope are used, then device complexity is reduced, but ablation consistency and efficiency deteriorate
Solution Approach 1:
The ablation device is designed with multi-functionality to address various clinical needs. The electrode array can be configured in different patterns and sizes to accommodate different target tissue volumes and locations. The device can deliver RF energy through multiple electrodes simultaneously or sequentially, providing versatile ablation capabilities. This universality maintains procedural efficiency and consistency across different patient cases without requiring multiple specialized devices.
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 efficient, uniform tissue ablation with reduced risk of auxiliary injuries and improved consistency, allowing for precise control over ablation volumes and minimizing tumor seeding.
Implementation Method 1
application of energy through the electrodes will generate a spherical volume of ablated tissue
Implementation Method 2
The electrodes are configured to encircle a target tissue or volume and create a spherical ablation pattern around a tissue volume including the target tissue when energized
Data Source
AI summary
A tissue ablation device and method for tissue ablation are described. The tissue ablation device comprises an energy source and an introducer coupled to the energy source, the introducer having a body, a proximal end, and a distal end. The introducer carries an electrode array that comprises a plurality of electrodes, each electrode of the plurality of electrodes is configured to extend from the body of the introducer when moved from a retracted state to a deployed state. The electrode array is designed to encircle a portion of a target tissue when the electrodes are extended into the deployed state and to form a relatively spherical shaped ablation pattern in a tissue volume surrounding the target tissue when energized by the energy source.