Irreversible Electroporation Ablation Device for Tissue Necrosis

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Solution Overview

Problem

Conventional electrical ablation techniques often cause permanent damage to healthy tissue due to thermal effects and are costly, invasive, and painful, with limitations in treating tissue within body lumens or cavities.

Innovation Solution

The development of electrical ablation systems using irreversible electroporation (IRE) technology, which applies controlled electric pulses to create necrotic zones without thermal damage, allowing for minimally invasive treatment of undesirable tissue through electrodes configured for various anatomical locations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional thermal ablation techniques (RF, laser, ultrasound) are used to treat undesirable tissue, then the tissue can be effectively ablated, but permanent damage occurs to healthy surrounding tissue due to thermal effects

Engineering Contradiction:
Improveablation effectivenessVSAvoidthermal damage to healthy tissue
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces thermal ablation mechanisms with electrical field-based irreversible electroporation. Instead of using thermal energy (heat) to destroy tissue, the invention applies electrical pulses that create permanent pores in cell membranes through electroporation, leading to cell death without significant thermal damage. This substitution of the underlying physical mechanism eliminates the harmful thermal effects while maintaining ablation effectiveness.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the fundamental parameter of energy delivery from thermal to electrical. By using controlled electrical pulse parameters (amplitude, duration, frequency) to induce irreversible electroporation, the system achieves tissue ablation through a different physical mechanism that does not rely on thermal conduction, thereby avoiding thermal damage to surrounding healthy tissue.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If surgical excision is used to remove undesirable tissue, then complete removal can be achieved, but it is invasive, costly, and requires recovery time

Engineering Contradiction:
Improvetissue removal completenessVSAvoidinvasiveness and recovery
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces mechanical surgical excision with non-invasive electrical field application. Instead of physically cutting and removing tissue through open surgery, the system uses electrical pulses delivered through electrodes to induce irreversible electroporation in target cells, achieving complete tissue removal through a non-invasive electrical mechanism that avoids surgical trauma and reduces recovery requirements.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Productivity

If conventional ablation devices are used to treat tissue within body lumens or cavities, then line-of-sight regions can be treated, but residual undesirable tissue remains within the cavity wall

Engineering Contradiction:
Improvetreatment coverageVSAvoidresidual tissue elimination
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent employs a balloon electrode that can be inflated within body lumens or cavities to conform to the cavity wall surface. This multi-functional design allows the device to treat both line-of-sight regions and residual tissue within the cavity wall by adapting to the specific geometry of the treatment site, ensuring comprehensive coverage without leaving residual undesirable tissue.

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

Solution Approach 2:

The use of a balloon electrode with a curved, conformable surface allows the device to adapt to the three-dimensional geometry of body lumens and cavities. The balloon's ability to expand and conform to the cavity wall enables electrical field penetration into previously inaccessible areas, effectively treating residual tissue that would otherwise remain untreated in conventional linear or rigid electrode configurations.

Inventive Principle:
Principle #14Spheroidality (Curvature)

4Reliability

If high temperature thermal therapies are used to cause cell necrosis, then ablation is achieved, but extraordinary pain is inflicted on the patient

Engineering Contradiction:
Improvecell necrosis achievementVSAvoidpatient pain
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent substitutes thermal necrosis mechanisms with electrical field-based irreversible electroporation. By applying electrical pulses that create permanent membrane pores without significant heat generation, the system achieves cell death through a non-thermal mechanism that avoids the extraordinary pain associated with high temperature thermal therapies, while still achieving complete cell necrosis.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

IRE ablation systems effectively treat diseased tissue and tumors with minimal damage to surrounding healthy tissue, reducing recovery time and pain, and are adaptable for use in diverse anatomical locations, including body lumens and cavities.

Implementation Method 1

The development of electrical ablation systems using irreversible electroporation (IRE) technology, which applies controlled electric pulses to create necrotic zones without thermal damage

Methodology Applied
Scientific EffectIrreversible electroporation: Electric Field

Data Source

PatentUS10004558B2Electrical ablation devices
Publication Date: 2018.06.26 CILAG GMBH INTERNATIONAL
  • US10004558B2 patent drawing
  • US10004558B2 patent drawing
  • US10004558B2 patent drawing

AI summary

An electrical ablation apparatus comprises first and second electrodes. Each electrode comprises a first end configured to couple an energy source and a second end configured to couple to a tissue treatment region. An energy source is coupled to the first and second electrodes. The energy source is configured to deliver a first series of electrical pulses sufficient to induce cell necrosis by irreversible electroporation and a second series of electrical pulses sufficient to induce cell necrosis by thermal heating, through at least one of the first and second electrodes. The first series of electrical pulses is characterized by a first amplitude, a first pulse length, and a first frequency. The second series of electrical pulses is characterized by a second amplitude, a second pulse length, and a second frequency.