Balloon Catheter Electrodes for Vessel Remodeling
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Solution Overview
Problem
Current treatments for atherosclerotic plaque, such as balloon angioplasty and stenting, often cause trauma to tissues and are not suitable for diffuse or tortuous arteries, leading to restenosis and other complications, and there is a need for methods that can remodel blood vessels without extreme dilation or implantation.
Innovation Solution
A catheter system that uses radially expanding balloons with electrodes to deliver RF, microwave, or ultrasound energy for gentle heating of plaque and healthy tissues, allowing for controlled tissue remodeling without significant injury, thereby increasing blood flow and avoiding the limitations of stenting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If balloon angioplasty is used to open occluded blood vessels, then the blood vessel can be opened, but significant tissue trauma is imposed limiting the benefits in time
Solution Approach 1:
The patent replaces the purely mechanical balloon dilation system with a combined thermal-mechanical system. RF electrodes are integrated into the balloon catheter to deliver controlled thermal energy to the plaque tissue, softening it and facilitating opening with reduced mechanical force and trauma to the vessel wall.
Solution Approach 2:
The patent changes the physical state of the plaque by applying controlled thermal energy. The RF heating raises the temperature of the plaque tissue to specific ranges (e.g., 50-70°C) to alter its mechanical properties, making it more compliant and easier to remodel without excessive mechanical trauma.
2Duration of action of stationary object
If stents are used to extend the beneficial opening of the blood vessel, then the vessel remains open longer, but mechanical fatigue, corrosion, and surgical removal risks are introduced
Solution Approach 1:
The patent extracts the implant component from the treatment system. Instead of deploying a permanent stent, the invention uses a temporary balloon catheter with RF electrodes that delivers thermal energy to remodel the plaque, then removes the catheter entirely, leaving no foreign body in the vessel.
Solution Approach 2:
The patent employs a disposable, non-implantable balloon catheter system. The catheter is inserted, delivers controlled RF heating to remodel the plaque, and is then removed. The system relies on the remodeled tissue structure to maintain vessel patency without requiring a permanent implant.
3Loss of substance
If atherectomy devices are used to remove plaque, then plaque can be excised, but the procedures have not gained widespread use due to disadvantages and limitations
Solution Approach 1:
The patent replaces mechanical plaque excision devices with a thermal energy delivery system. RF electrodes heat the plaque tissue to facilitate controlled remodeling and softening, allowing plaque modification without complex mechanical cutting or atherectomy mechanisms.
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 system effectively remodels atherosclerotic tissues by heating to moderate temperatures, reducing recoil and the risk of restenosis, and is suitable for treating diffuse and tortuous arteries, including those where stenting is not viable, while minimizing complications and the need for invasive procedures.
Implementation Method 1
plaque, fibrous vulnerable or 'hot' plaques, along with healthy tissues are heated by the energized electrodes using RF energy
Implementation Method 2
plaque, fibrous vulnerable or 'hot' plaques, along with healthy tissues are heated by the energized electrodes using RF energy, microwave energy
Implementation Method 3
plaque, fibrous vulnerable or 'hot' plaques, along with healthy tissues are heated by the energized electrodes using RF energy, microwave energy, ultrasound energy
Data Source
Figure 1a~1f
Figure 1g~1i
Figure 2~3
AI summary
The present invention relates to an apparatus for treatment of a blood vessel of a patient body, the vessel having a lumen and a vessel wall. The apparatus comprises a catheter body having a proximal end and a distal end with an axis therebetween as well as a radially expandable member supported by the distal end of the catheter body, the expandable member having a low profile insertion configuration and a larger profile configuration. The apparatus additionally comprises a plurality of bipolar electrode pairs carried by the expandable member so that expansion of the expandable member within the lumen urges each electrode pair against the vessel wall, wherein each bipolar electrode pair has an inner edge spacing between electrodes of x mm and each electrode has a length of L mm; and an electrical energy source configured to apply a power in Watts for a time of t seconds such that: power=b*x∧2*L*t∧−0.59, wherein b is a parameter in a range of 0.2 to 0.6.