Insulated Electrode Members for Thrombus-Free Tissue Fusion

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Solution Overview

Problem

Conventional medical devices for closing defects like patent foramen ovale (PFO) face challenges with thrombus attachment to electrode members when applying electric energy, leading to potential stroke risks and positional instability due to foreign substances and thermal contraction issues.

Innovation Solution

A medical device with electrode members coated with an electrical insulator along their axial length to prevent thrombus attachment, featuring a non-electrically-conductive attachment portion and an energy supply unit to ensure safe and certain tissue fusion or necrosis, with adjustable surface areas and materials to prevent heat transfer and thrombus formation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If electric energy is applied to the biological tissue using exposed electrodes, then tissue fusion or necrosis can be achieved, but thrombus attachment occurs on the electrode surface

Engineering Contradiction:

Improvetissue fusion reliabilityVSAvoidthrombus attachment

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrode is designed with different surface properties at different locations: the distal end portion (contacting tissue) has high electrical conductivity for effective energy delivery, while the proximal end portion (exposed to blood) is coated with an electrical insulator to prevent thrombus attachment. This local differentiation resolves the contradiction between achieving reliable tissue fusion and preventing harmful thrombus formation.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

An electrical insulator coating is introduced as an intermediary layer on the proximal end of the electrode. This intermediary prevents direct contact between the conductive electrode surface and the blood, thereby eliminating the harmful effect of thrombus attachment while allowing the distal end to maintain its therapeutic function.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Area of stationary object

If the electrode surface area is increased to improve tissue contact, then thermal contraction of tissue may expose more electrode surface to blood, increasing thrombus attachment risk

Engineering Contradiction:

Improveelectrode tissue contact areaVSAvoidexposed electrode surface area

Core Design Contradiction:

Area of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The electrode design applies local quality by differentiating the surface properties along the electrode length. The distal end portion maintains a larger surface area for effective tissue contact and thermal contraction accommodation, while the proximal end portion is coated with an electrical insulator. This resolves the contradiction by ensuring that any increased exposed surface area due to thermal contraction occurs only on the insulator-coated proximal end, preventing thrombus attachment.

Inventive Principle:

Principle #3Local quality

3Reliability

If foreign substances (membranes or anchor members) are used to close the defect, then the defect can be closed, but thrombus attachment occurs on these foreign substances

Engineering Contradiction:

Improvedefect closing effectivenessVSAvoidthrombus attachment to foreign substances

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention extracts and removes the problematic foreign substances (membranes or anchor members) from the treatment approach. Instead of using these substances that inherently cause thrombus attachment, the invention employs direct electrode-mediated tissue fusion to close the defect, eliminating the source of thrombus formation while maintaining defect closing effectiveness.

Inventive Principle:

Principle #2Taking out (Extraction)

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

The device effectively prevents thrombus attachment and ensures stable, safe, and efficient tissue fusion or necrosis procedures by controlling electric energy distribution and heat transfer, reducing the risk of stroke and improving procedural accuracy and speed.

Implementation Method 1

a region of a predetermined length in a direction of an axial line from the attachment portion in at least one of the electrode members within the first electrode member and the second electrode member is coated with an electrical insulator

Methodology Applied

Scientific EffectElectrical insulation: Electrical Resistance

Implementation Method 2

an energy supply unit configured to supply electric energy to between the first electrode member and the second electrode member

Methodology Applied

Scientific EffectJoule heating: Joule Heating

Implementation Method 3

When the biological tissue is thermally contracted, there is also a fear that the proximal side of the electrode member contacting with the biological tissue is exposed

Methodology Applied

Scientific EffectThermal contraction: Thermal Contraction

Data Source

PatentUS8382752B2Medical device

Publication Date: 2013.02.26 TERUMO KK

AI summary

A medical device for fusing or necrosing a biological tissue, including a first electrode member and a second electrode member protruded from a non-electrically-conductive attachment portion configured to sandwich the biological tissue; and an energy supply unit configured to supply electric energy to between the first electrode member and the second electrode member, wherein the region of a predetermined length in a direction of axial line from the attachment portion in at least one of the electrode members within the first electrode member and the second electrode member is coated with an electrical insulator.