Flexible RF Ablation Needle with Helical Electrode

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Solution Overview

Problem

Current methods for treating lung cancer, particularly in the form of pulmonary nodules, face challenges such as invasive procedures, high risks of complications like pneumothorax and excessive bleeding, and difficulty in accessing deep lung regions due to the rigidity of conventional electrical ablation probes and limitations of bronchoscopic approaches.

Innovation Solution

A device comprising a guide sheath and a catheter with a distal port and electrodes, where a second electrode can extend from the first electrode to form a helical configuration, allowing for bipolar radiofrequency ablation, and is constructed from shape-memory materials for flexibility, enabling precise energy delivery through a bronchoscope with ultrasound guidance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional electrical ablation probes are used, then ablation of lung tissue can be achieved, but the procedure carries high risks of pneumothorax, excessive bleeding, and other complications

Engineering Contradiction:

Improvesafety of ablation procedureVSAvoidcomplications such as pneumothorax and excessive bleeding

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The ablation probe is designed with a flexible catheter shaft that can navigate through the bronchial tree to reach peripheral lung lesions. The flexibility of the catheter allows it to conform to the anatomical structures, enabling access to deep lung regions while minimizing trauma to surrounding tissues and reducing the risk of pneumothorax and bleeding

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The invention uses the bronchial tree as an intermediary pathway to deliver the ablation probe to the target lesion. Instead of directly piercing the lung parenchyma, the probe is advanced through the airways, which serves as a natural conduit, thereby reducing direct tissue disruption and associated complications

Inventive Principle:

Principle #24Intermediary (Mediator)

2Adaptability or versatility

If rigid ablation probes are used, then adequate energy delivery can be achieved, but the probes cannot reach certain areas of the pulmonary anatomy

Engineering Contradiction:

Improveaccess to deep lung regionsVSAvoidrigidity of probe

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The catheter is designed with dynamic flexibility, allowing it to bend and navigate through the complex three-dimensional bronchial tree. The flexible construction enables the probe to reach peripheral and deep lung regions that are inaccessible to rigid probes, while still maintaining the ability to deliver adequate ablation energy when the distal electrode contacts the target tissue

Inventive Principle:

Principle #15Dynamics

3Ease of operation

If bronchoscopic approaches are used, then access to airways is achieved, but the bronchoscope cannot enter very small peripheral lung passages

Engineering Contradiction:

Improvenavigation through airwaysVSAvoidreach of bronchoscope

Core Design Contradiction:

Ease of operationVSLength of moving object

Solution Approach 1:

The ablation catheter is designed to be nested within or advanced through the bronchoscope. This nested configuration allows the flexible catheter to utilize the bronchoscope as a guide and protective sheath during navigation, enabling access to small peripheral passages while maintaining control and visualization through the bronchoscopic approach

Inventive Principle:

Principle #7Nested doll (Nesting)

4Power

If a straight electrode configuration is used, then simple delivery is achieved, but insufficient energy delivery to dispersed tissue regions

Engineering Contradiction:

Improveenergy delivery capabilityVSAvoidelectrode configuration

Core Design Contradiction:

PowerVSDevice complexity

Solution Approach 1:

The second electrode is designed to change its configuration dynamically based on the treatment requirements. It can be delivered in a compact, straight configuration for easy insertion, then deployed into a helical or expanded configuration at the distal end to increase the ablation surface area and improve energy delivery to dispersed tissue regions. This dynamic transformation allows the electrode to adapt to different treatment scenarios without requiring multiple separate electrodes

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

This solution allows for safer and more precise ablation of lung tissue with reduced complications, improved access to deep lung regions, and enhanced energy delivery, increasing the effectiveness of lung nodule treatment while minimizing trauma.

Implementation Method 1

the distal section of the second electrode that is extended from the first electrode changes from the first configuration to a second configuration. The second configuration includes a helical configuration

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS20230380887A1Flexible RF ablation needle

Publication Date: 2023.11.30 GYRUS ACMI INC

AI summary

Devices, methods, and systems for the treatment of tissue using energy delivery. Specifically, certain embodiments may be used for the treatment of lung tissue, such as lung nodules, using RF ablation, via a catheter provided with a first electrode attached to a distal end of the catheter, wherein the first electrode is hollow, wherein the first electrode comprises a piercing tip configured to pierce through an airway wall and a second electrode received in a movable manner within the first electrode, wherein the second electrode is extendable from the first electrode to form a first extended configuration.