Adjustable Needle Electrodes for Precise Ablation Volumes

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Solution Overview

Problem

Current bipolar electroporation devices have limitations such as lower ablation volumes, arcing issues, and complexity, while monopolar devices offer larger ablation volumes but with increased risks and complexity, necessitating an adjustable length electrode to ensure precise targeting and minimize damage to non-targeted anatomy.

Innovation Solution

An energy-delivering assembly with adjustable electrode portions and insulation members, allowing for varying lengths and configurations to optimize energy delivery and minimize tissue damage, featuring a sharp distal tip for tissue puncture and a lumen for material delivery or aspiration, with a handle for controlling electrode position and energy application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If bipolar devices are used for electroporation treatment, then muscle contractions are reduced, but ablation volumes are lower and device complexity increases

Engineering Contradiction:
Improvemuscle contractionsVSAvoidablation volume
Core Design Contradiction:
Object-affected harmful factorsVSVolume of stationary object

Solution Approach 1:

The electrode assembly allows dynamic adjustment of the active electrode length by moving the insulation member along the electrode shaft. This enables the ablation volume to be adapted to match the target tumor size, providing larger ablation volumes for bigger tumors while maintaining the muscle contraction benefits of bipolar configuration.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device changes the effective length parameter of the electrode by allowing the insulation member to slide along the shaft. This parameter adjustment enables optimization of the electric field distribution to achieve appropriate ablation volumes while maintaining the bipolar advantage of reduced muscle contractions.

Inventive Principle:
Principle #35Parameter changes

2Volume of stationary object

If monopolar devices are used for electroporation treatment, then ablation volumes are larger, but arcing risks increase and device complexity increases

Engineering Contradiction:
Improveablation volumeVSAvoidarcing
Core Design Contradiction:
Volume of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The device segments the electrode into an active portion and an insulated portion that can be independently adjusted. This segmentation allows the active electrode length to be optimized for the specific tumor size, enabling larger ablation volumes when needed while maintaining safety through controlled electrode geometry that reduces arcing risks.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

By allowing adjustment of the active electrode length parameter, the device can optimize the voltage and current distribution to achieve larger ablation volumes while maintaining safe operating parameters that minimize arcing. The insulation member position directly controls this critical parameter.

Inventive Principle:
Principle #35Parameter changes

3Device complexity

If fixed length electrodes are used, then device complexity is reduced, but precision in targeting specific tumor volumes is compromised

Engineering Contradiction:
Improvedevice structureVSAvoidtargeting precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The device transforms a static fixed-length electrode into a dynamic adjustable-length electrode. The insulation member can be positioned at different locations along the shaft to expose different lengths of the active electrode, enabling precise adaptation to various tumor sizes and shapes while adding minimal complexity through a simple sliding mechanism.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device allows preliminary adjustment of the electrode length before insertion and activation. The insulation member can be positioned to expose the desired electrode length in advance, ensuring precise targeting of the tumor volume from the beginning of the procedure without requiring complex intra-procedural adjustments.

Inventive Principle:
Principle #10Preliminary action

4Volume of stationary object

If longer electrodes are used, then ablation volumes increase, but risk of ablation damage to non-targeted anatomy increases

Engineering Contradiction:
Improveablation volumeVSAvoiddamage to healthy tissue
Core Design Contradiction:
Volume of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The device applies local quality control by allowing selective exposure of the electrode length that corresponds to the specific tumor location and size. The insulation member can be positioned to expose only the portion of the electrode needed for the target tumor, concentrating the ablation effect locally while protecting surrounding healthy tissue from unintended thermal or electrical damage.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The dynamic adjustment capability allows the electrode length to be optimized for each specific procedure and patient anatomy. The insulation member can be repositioned to expose the minimum necessary electrode length to achieve the required ablation volume, thereby reducing the risk of damaging non-targeted anatomy while still treating the tumor effectively.

Inventive Principle:
Principle #15Dynamics

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 energy delivery to target sites with adjustable ablation volumes, reducing muscle contractions and arcing risks, while ensuring full ablation of tumors and minimizing damage to surrounding healthy tissue.

Implementation Method 1

the device is activated, such as by generating an electric field between and/or around the two electrodes of the device

Methodology Applied
Scientific EffectElectric field: Electric Field

Implementation Method 2

energy may be applied to perform radiofrequency ablation (RFA), electroporation, and/or irreversible electroporation (IRE) as a mode of treating various conditions

Methodology Applied
Scientific EffectElectroporation:

Implementation Method 3

Radiofrequency ablation causes thermal coagulation of the tissue

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS20250010066A1Adjustable needle electrodes for medical procedures and associated systems and methods
Publication Date: 2025.01.09 BOSTON SCIENTIFIC SCIMED INC
  • US20250010066A1 patent drawing
  • US20250010066A1 patent drawing
  • US20250010066A1 patent drawing

AI summary

Bipolar or monopolar adjustable energy-delivering assemblies. The assemblies are configured for transluminal (e.g., endoscopic) delivery within a patient. A first energy-delivering member defines a first electrode portion formed of an electrically-conductive material so that energy may be delivered to the first energy-delivering member to create an energy field along the first electrode portion to apply to a target site within a patient. The first energy-delivering member may define a lumen therethrough allowing delivery of materials distally therethrough to a target site and/or allows materials from the target site to be aspirated proximally therethrough. Optionally, a second energy-delivering member and a second insulation member form a second electrode portion. Optionally, either or both electrode portions may be adjustable. Additionally or alternatively, the first electrode portion and the second electrode portion are adjustable with respect to each other.