Balloon Catheter Electrodes for Irreversible Electroporation
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Solution Overview
Problem
Current methods for preventing vascular re-stenosis after angioplasty, such as drug-eluting stents, face challenges including increased risk of blood clots, stent fracture, and other complications, necessitating a safer and more effective approach that does not require stent placement.
Innovation Solution
A balloon catheter device equipped with electrodes that administer electrical pulses for irreversible electroporation to the vascular tissue, reducing neointima formation and preventing re-stenosis without the use of drugs or stents, by selectively ablating smooth muscle cells to prevent scar tissue growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If drug-eluting stents are used to prevent re-stenosis, then re-stenosis rate is reduced, but risk of blood clots and stent fracture increases
Solution Approach 1:
The invention extracts and removes the stent structure entirely, using only balloon-mediated electroporation to prevent re-stenosis. This eliminates all stent-related complications including blood clot risk, stent fracture, and drug elution issues while maintaining re-stenosis prevention through selective smooth muscle cell ablation
Solution Approach 2:
The invention replaces the mechanical stent structure with an electrical field-based treatment. Electroporation uses electrical energy to selectively destroy smooth muscle cells without requiring any implanted mechanical device, thereby eliminating mechanical complications while achieving the same therapeutic goal
2Object-affected harmful factors
If cutting wire balloon catheters are used to score lesions, then procedural vessel trauma is reduced, but endothelial cell re-growth and re-stenosis are not effectively prevented
Solution Approach 1:
The invention replaces mechanical scoring with electrical field application. Instead of physically cutting or scoring the vessel wall, electroporation uses electrical energy to selectively ablate smooth muscle cells, achieving better re-stenosis prevention without the limitations of mechanical approaches
Solution Approach 2:
The invention changes the fundamental parameter of tissue interaction from mechanical force to electrical field intensity. By controlling voltage and pulse duration, electroporation achieves selective cell death based on electrical permeability thresholds, providing a more precise and effective method for preventing smooth muscle cell proliferation
3Productivity
If balloon angioplasty is performed to widen vessel lumen, then blood flow is restored, but vessel wall trauma is created leading to re-stenosis
Solution Approach 1:
The invention applies electroporation immediately following angioplasty while the balloon is still inflated and the vessel wall is exposed. This preliminary action targets the freshly injured smooth muscle cells before they can proliferate and form neointima, effectively preventing re-stenosis while preserving the blood flow restoration achieved by angioplasty
Solution Approach 2:
The invention converts the harmful effect of angioplasty-induced vessel wall trauma into a beneficial opportunity. The mechanical injury that normally triggers pathological smooth muscle cell proliferation is instead used to expose the cells to electroporation, which selectively destroys them and prevents re-stenosis, transforming a negative outcome into a positive therapeutic effect
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 method effectively reduces neointimal formation and prevents re-stenosis by selectively destroying smooth muscle cells through irreversible electroporation, maintaining the integrity of the arterial structure and avoiding thermal damage, thus ensuring long-term patency of the vessel.
Implementation Method 1
The power source provides electrical pulses to the electrodes for durations, voltages, current amounts and combinations thereof so as to provide sufficient electrical flow to substantially all of the vascular cells in the area of an artery (which has been subjected to trauma) to irreversible electroporation (IRE)
Data Source
AI summary
Restenosis or neointimal formation may occur following angioplasty or other trauma to an artery such as by-pass surgery. This presents a major clinical problem which narrows the artery. The invention provides a balloon catheter with a particular electrode configuration. Also provided is a method whereby vascular cells in the area of the artery subjected to the trauma are subjected to irreversible electroporation which is a non-thermal, non-pharmaceutical method of applying electrical pulses to the cells so that substantially all of the cells in the area are ablated while leaving the structure of the vessel in place and substantially unharmed due to the non-thermal nature of the procedure.