RF Catheter Tissue Remodeling for Atherosclerotic Plaque
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Solution Overview
Problem
Current methods for treating atherosclerotic plaque, such as stenting and balloon angioplasty, often result in trauma to the tissues, restenosis, and are not suitable for diffuse or tortuous arteries, while alternative approaches like atherectomy have not gained widespread success due to their own limitations.
Innovation Solution
A method and system that uses controlled thermal energy to remodel artery tissue by heating specific zones with RF energy, avoiding muscular contraction and long-term occlusion, allowing for vasodilation and plaque debulking without the need for extreme dilation or stenting, using a catheter with electrodes to deliver bipolar tissue remodeling energy and maintain temperatures between 47° C. and 65° C. to treat both healthy and diseased tissues effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If balloon angioplasty is used to open occluded blood vessels, then the blood vessel opening is achieved, but tissue trauma and restenosis occur
Solution Approach 1:
The patent replaces the mechanical balloon dilation system with a thermal energy delivery system. RF electrodes deliver controlled thermal energy to heat and remodel plaque tissue, eliminating the need for mechanical balloon expansion that causes trauma. The thermal energy selectively heats plaque to temperatures that modify its mechanical properties, allowing plaque softening and vessel opening without mechanical force.
Solution Approach 2:
The patent changes the physical state of plaque through controlled temperature elevation. By heating plaque to specific temperature ranges (47-65°C), the plaque undergoes thermal remodeling that alters its mechanical properties, making it softer and more compliant. This parameter change allows the plaque to be reshaped without mechanical trauma.
2Duration of action of stationary object
If stenting is used to extend blood vessel opening, then the vessel remains open longer, but implants remain in the body with risks of mechanical fatigue and corrosion
Solution Approach 1:
The patent extracts and removes the need for permanent implant devices. Instead of placing a stent in the vessel, the thermal energy system remodels the plaque in-place, allowing the vessel to maintain patency through tissue modification rather than mechanical support. This eliminates the implant entirely, removing all associated risks of mechanical fatigue, corrosion, and implant-related complications.
3Loss of substance
If atherectomy is used to remove plaque, then plaque debulking is achieved, but the procedure has not gained widespread success due to limitations
Solution Approach 1:
The patent replaces mechanical plaque removal (atherectomy) with thermal energy delivery. Instead of physically cutting or shaving plaque with mechanical devices, RF electrodes deliver thermal energy that heats and remodels the plaque in-place. This achieves plaque debulking through thermal softening and tissue modification, eliminating the mechanical complexity and limitations of atherectomy devices.
4Loss of substance
If thermal energy is used to remodel tissue, then plaque debulking is achieved, but selective heating of diseased tissue while minimizing damage to healthy tissue is challenging
Solution Approach 1:
The patent applies thermal energy with local quality control through electrode placement and impedance-based energy distribution. The RF electrodes are positioned to contact plaque directly, and energy delivery is modulated based on local tissue impedance characteristics. Diseased tissue with different electrical properties absorbs more energy, achieving selective heating and remodeling of plaque while sparing adjacent healthy tissue.
Solution Approach 2:
The patent exploits parameter differences between healthy and diseased tissue, specifically electrical impedance. Plaque and healthy tissue have different impedance characteristics, allowing the RF system to deliver energy preferentially to the plaque. By monitoring and controlling energy delivery parameters, the system achieves selective thermal remodeling of diseased tissue while maintaining safe temperatures in healthy tissue.
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
This approach effectively remodels artery tissue, reduces plaque burden, increases blood flow, and prevents restenosis by selectively heating diseased tissue while minimizing damage to healthy tissue, offering a non-invasive solution for treating atherosclerotic plaque without the need for stents or aggressive dilation.
Implementation Method 1
transmitting desired quantities of energy intended to remodel the tissue ('tissue remodeling energy') from the coupled probe into each of a plurality of discrete tissue volumes ('remodeling zones') in the artery tissue so that the tissue remodeling energy heats the plurality of remodeling zones
Implementation Method 2
heating specific zones with RF energy, avoiding muscular contraction and long-term occlusion, allowing for vasodilation and plaque debulking without the need for extreme dilation or stenting, using a catheter with electrodes to deliver bipolar tissue remodeling energy and maintain temperatures between 47° C. and 65° C.
Data Source
AI summary
Methods and systems are disclosed for treating diseased tissue by gentle heating. The method induces vasodilation on tissue disposed about an lumen having both healthy tissue and diseased tissue. The method includes coupling a probe surface to the luminal tissue at a target location and transmitting desired quantities of tissue remodeling energy from the coupled probe into each of a plurality of discrete remodeling zones in the luminal tissue so that the tissue remodeling energy heats the plurality of remodeling zones, the remodeling energy being configured to avoid muscular contraction and inhibit both acute and long-term occlusion of the lumen.