Negative Charge Bias for RF Ablation Catheter Coagulum Control

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Solution Overview

Problem

During medical procedures like RF ablation, coagulum formation can occur due to direct fibrinogen binding and conversion to fibrin, leading to thromboembolic events despite anticoagulant use, posing a risk of embolization and increasing impedance between catheter and tissue.

Innovation Solution

Applying a negative charge to conductive surfaces interfacing with blood and using high pH solutions or RGD/ClfA peptides to inhibit fibrinogen binding and coagulum formation, reducing the need for anticoagulants like heparin.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If RF ablation is performed to treat arrhythmia, then the arrhythmia can be terminated or reduced, but coagulum formation occurs along the catheter tip and ablated tissue, increasing embolization risk

Engineering Contradiction:
Improvearrhythmia treatment effectivenessVSAvoidcoagulum formation and embolization risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention converts the harmful effect of RF energy on fibrinogen into a beneficial outcome by controlling the charge state of the catheter surface. By maintaining a negative charge on the catheter tip during RF ablation, the process prevents fibrinogen binding and coagulum formation, thereby eliminating the embolization risk while preserving the arrhythmia treatment effectiveness.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The invention changes the electrical parameter (charge state) of the catheter surface from neutral or positive to negative during RF ablation. This parameter change fundamentally alters the interaction between the catheter surface and fibrinogen, preventing binding and coagulum formation while maintaining the therapeutic effect.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If heparinization is used to reduce thrombus formation, then thrombin levels are reduced, but coagulum can still form due to direct fibrinogen conversion to fibrin during RF ablation

Engineering Contradiction:
Improvethrombus formation reductionVSAvoidcoagulum formation from fibrinogen conversion
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention addresses the limitation of heparinization by converting the harmful RF-induced fibrinogen conversion into a beneficial process. The negative charge on the catheter tip prevents fibrinogen binding and subsequent conversion to fibrin, thereby eliminating coagulum formation even when heparin is not adequately supplied.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The negative charge on the catheter surface acts as an intermediary that prevents the harmful interaction between RF energy and fibrinogen. This intermediary effect blocks the conversion pathway from fibrinogen to fibrin, preventing coagulum formation without requiring adequate heparinization.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If anticoagulant drugs like heparin are administered, then thrombin activity is inhibited, but fibrinogen can still bind to catheter surfaces and form coagulum

Engineering Contradiction:
Improvethrombin inhibitionVSAvoidfibrinogen binding and coagulum formation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention transforms the harmful fibrinogen binding process into a beneficial outcome by applying a negative charge to the catheter tip. This charge state prevents fibrinogen binding and coagulum formation, thereby eliminating the need for adequate anticoagulant supply while maintaining patient safety.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The invention changes the surface charge parameter of the catheter from neutral to negative, which fundamentally alters the binding characteristics for fibrinogen. This parameter change prevents fibrinogen adsorption and coagulum formation, rendering anticoagulant drugs unnecessary for preventing this specific harmful effect.

Inventive Principle:
Principle #35Parameter changes

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

Substantially reduces the risk of thromboembolism and coagulum formation during medical procedures by repelling fibrinogen and preventing its binding to electrode surfaces, thereby minimizing the usage of anticoagulant drugs.

Implementation Method 1

the application of the negative charge at the instrument-blood interface can reduce the fibrinogen deposition and the formation of coagulum because fibrinogen molecules in general are negatively charged at neutral pH levels

Methodology Applied
Scientific EffectElectrostatic repulsion: Ion Repulsion/Attraction

Implementation Method 2

some embodiments of the instrument may be configured to irrigate the instrument-blood interface with RGD/ClfA peptides, a bicarbonate solution (or other high pH solution), or both to further repel the fibrinogen and thereby inhibit the formation of coagulum

Methodology Applied
Scientific EffectChemical interaction: Chemical Bonding

Data Source

PatentUS9585708B2Controlling coagulum formation
Publication Date: 2017.03.07 MAYO FOUNDATION FOR MEDICAL EDUCATION & RESEARCH
  • US9585708B2 patent drawing
  • US9585708B2 patent drawing
  • US9585708B2 patent drawing

AI summary

Some embodiments of a medical instrument can be configured to reduce the formation of coagulum by delivering a negative charge bias to conductive surfaces that interface with blood or bodily tissue during a medical procedure. The application of the negative charge at the instrument-blood interface can reduce the fibrinogen deposition and the formation of coagulum because fibrinogen molecules in general are negatively charged at neutral pH levels. In addition, some embodiments of the instrument may be configured to irrigate the instrument-blood interface with RGD/ClfA peptides, a bicarbonate solution (or other high pH solution), or both to further repel the fibrinogen and thereby inhibit the formation of coagulum. Accordingly, some embodiments of the medical instrument can substantially reduce the risks of thromboembolism during particular medical procedures.