Segmented Needle Array for Selective Tumor Ablation

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Solution Overview

Problem

Current thermal ablation therapies lack control and selectivity, often damaging useful tissue structures along with targeted tissue, while electroporation methods can have systemic side effects due to the need for additional agents.

Innovation Solution

A tissue destruction system with adjustable and manipulable electrodes and fluid infusion capabilities, allowing for precise delivery of electrical pulses for irreversible electroporation and thermal ablation, either separately or in combination, to enhance therapeutic control and minimize side effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If thermal ablation is used to destroy targeted tissue, then tissue destruction is achieved, but control and selectivity are poor causing damage to useful tissue structures

Engineering Contradiction:
Improvespatial control precisionVSAvoiddamage to useful tissue structures
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The device segments the electrode into multiple independently controllable segments along its length. Each segment can be individually activated or deactivated, allowing precise spatial control over which areas deliver thermal ablation energy. This segmentation enables selective targeting of tumor regions while sparing adjacent healthy structures that would otherwise be damaged by conventional thermal ablation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The electrode incorporates dynamic control capabilities where the activation state of each segment can be changed in real-time during the procedure. This dynamic control allows the physician to adapt the treatment pattern to match the actual tumor geometry and protect critical structures, improving spatial precision and reducing collateral damage compared to static thermal ablation approaches.

Inventive Principle:
Principle #15Dynamics

2Manufacturing precision

If electroporation with additional agents is used to achieve selective cell death, then selective cell death is improved, but systemic side effects increase

Engineering Contradiction:
Improveselectivity of cell deathVSAvoidsystemic side effects
Core Design Contradiction:
Manufacturing precisionVSObject-generated harmful factors

Solution Approach 1:

The device merges irreversible electroporation (IRE) capability with thermal ablation capability into a single integrated electrode system. By combining these two modalities, the device can achieve selective cell death through IRE while using thermal ablation as an adjunct to enhance local tissue destruction. This combination allows for improved selectivity without relying solely on systemically administered agents, thereby reducing systemic side effects.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The electrode is designed with multi-functionality, capable of delivering both IRE pulses and thermal ablation energy through the same device platform. This universal design eliminates the need for separate device insertions or systemic agent administration, achieving selective cell death through localized physical energy delivery while minimizing systemic exposure and associated side effects.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Manufacturing precision

If physician control over electrode exposure is enhanced, then therapeutic precision is improved, but device complexity increases

Engineering Contradiction:
Improvetherapeutic precisionVSAvoidelectrode control mechanism complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The electrode structure employs a nested design where segmented electrode elements are housed within a delivery catheter. The segments can be sequentially deployed or retracted in a controlled manner, providing precise therapeutic control. This nested architecture allows complex functionality to be achieved through a relatively simple delivery mechanism, minimizing the increase in device complexity while maintaining high therapeutic precision.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The electrode design allows segments to be temporarily deactivated or retracted during the procedure and then reactivated or redeployed as needed. This ability to discard (deactivate) and recover (reactivate) specific segments provides flexible therapeutic control without requiring permanent structural complexity, enabling precise dose control and adaptation to changing treatment requirements.

Inventive Principle:
Principle #34Discarding and recovering

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 approach provides greater physician control over tissue destruction, allowing for selective targeting of tumors while minimizing damage to surrounding tissue, and enables the combination of therapies to enhance treatment efficacy and reduce systemic side effects.

Implementation Method 1

Electroporation operates by applying electrical pulses that cause cell membranes to alter, creating pores. Above a first threshold electrical field, the cell membranes begin to form pores. Above a second, higher threshold field, those pores can become irreversible, leading to cell death.

Methodology Applied
Scientific EffectElectroporation:

Implementation Method 2

Cryoablation and thermal ablation use cold and heat, for example, to destroy tissue. Thermal ablation can be effective and very useful

Methodology Applied
Scientific EffectThermal ablation: Heating

Data Source

PatentEP3742998B1Enhanced needle array and therapies for tumor ablation
Publication Date: 2023.11.15 BOSTON SCIENTIFIC SCIMED INC
  • EP3742998B1 patent drawingFigure 1
  • EP3742998B1 patent drawingFigure 2
  • EP3742998B1 patent drawingFigure 3

AI summary

Novel and versatile apparatuses for delivering one or more of thermal ablation and irreversible electroporation therapies to target tissue. In some examples, a device includes at its distal end a plurality of electrodes that can be advanced or retracted to pierce patient tissue, with a variable position and size shaft electrode provided near the distal end of the device to allow manipulation of therapy fields to achieve various tissue destruction field shapes. A number of method of use examples are described as well.