High-Voltage RF Ablation Device for Deep Lesions

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Solution Overview

Problem

Current medical treatments for creating deep lesions, such as those needed for cardiac conditions, often require prolonged energy application and high temperatures, which can lead to unintended tissue damage and patient discomfort due to excess heat at the tissue surface.

Innovation Solution

A system utilizing high-frequency alternating current radiofrequency energy, delivered through a medical device with multiple electrodes, that combines heat and electroporation to create deep lesions without excessive heat at the tissue surface, using voltages between 500 volts RMS and 3000 volts RMS, and allowing for programmable energy delivery in unipolar, bipolar, or combination modes to achieve effective ablation while maintaining tissue surface temperatures below 45°C.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If high temperatures and prolonged energy application are used to create deep lesions, then the depth and effectiveness of ablation is improved, but unintended tissue damage and patient discomfort occur due to excess heat at the tissue surface

Engineering Contradiction:
Improvelesion depthVSAvoidexcess heat damage
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent changes the voltage parameter to extremely high levels (500-3000 volts RMS) while using radiofrequency energy, shifting from conventional low-voltage thermal ablation to high-voltage electroporation-based ablation. This parameter change enables deep lesion creation through electroporative mechanisms rather than purely thermal mechanisms, reducing surface heat damage

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system applies radiofrequency energy in periodic pulses rather than continuous delivery, allowing tissue cooling between pulses and preventing excessive heat accumulation at the tissue surface while still achieving deep les ion formation through repeated electroporation events

Inventive Principle:
Principle #19Periodic action

2Reliability

If high-voltage electrical field pulses are applied to achieve electroporation and cell death, then ablation effectiveness is improved, but muscle contractions occur causing burning sensation or intense pain in patients

Engineering Contradiction:
Improveablation effectivenessVSAvoidpatient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses high-frequency radiofrequency alternating current (AC) instead of direct current (DC) pulses, and operates at voltages that produce electroporation without triggering significant muscle contractions. The high frequency and AC nature of the energy delivery changes the physiological response while maintaining electroporation effectiveness

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The periodic pulsed delivery of high-voltage RF energy allows electroporation to occur during the pulse while minimizing sustained muscle contraction and associated pain. The intermittent nature of the energy delivery reduces the duration of painful muscle contractions

Inventive Principle:
Principle #19Periodic action

3Volume of moving object

If conventional RF ablation is used to create deep lesions, then ablation depth is improved, but charring and micro embolus formation occur due to excessive surface heat

Engineering Contradiction:
Improvelesion depthVSAvoidcharring and micro emboli
Core Design Contradiction:
Volume of moving objectVSObject-generated harmful factors

Solution Approach 1:

The system uses extremely high voltage (500-3000 volts RMS) radiofrequency energy that produces electroporative ablation rather than purely thermal ablation. This fundamental parameter change in voltage level and energy delivery mechanism creates lesions through cell membrane permeabilization and subsequent cell death without the excessive surface heating that causes charring and micro emboli

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces the conventional thermal-mechanical ablation process with an electroporation-based process. Instead of relying on sustained high temperatures to cook and carbonize tissue, the system uses high-voltage electrical fields to create irreversible pores in cell membranes, leading to cell death through osmotic imbalance and content leakage without significant thermal damage

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

Enables the creation of deep lesions without causing patient discomfort or unintended tissue damage, as the system effectively uses electroporation and heat ablation in a controlled manner to achieve tissue damage without substantial heat increase, reducing the risk of micro emboli and charring.

Implementation Method 1

Ablation, such as of tumor or liver cells, occurs when cells are exposed to high-voltage electrical field pulses. In the presence of these pulses, the electrochemical potential across the cell membrane is altered and instabilities in the polarized lipid bilayer are induced, which may lead to the development of irreversible pores (or enlargement of existing pores) in the cell membrane.

Methodology Applied
Scientific EffectElectroporation: Electro-Osmosis

Implementation Method 2

The system of the present invention involve the application of higher voltage radiofrequency energy to use both heat and electroporation to perform ablation while avoiding undesired tissue damage due to excess heat at the tissue surface.

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Data Source

PatentEP2892455B1Device for ablating and electroporating tissue cells
Publication Date: 2017.06.28 MEDTRONIC ABLATION FRONTIERS LLC
  • EP2892455B1 patent drawingFigure 1
  • EP2892455B1 patent drawingFigure 2
  • EP2892455B1 patent drawingFigure 3A~3B

AI summary

A medical system having a medical device and a computer configured to treat target tissue cells using the medical device, the medical device being configured to selectively deliver energy at a voltage at which tissue electroporation occur, a voltage at which heat ablation occurs, a voltage between the voltage at which tissue electroporation occurs and the voltage at which heat ablation occurs.