Catheter Balloon Electrodes Remodel Atherosclerotic Plaque

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Solution Overview

Problem

Current treatments for atherosclerotic plaque, such as stenting and balloon angioplasty, often result in restenosis, trauma to tissues, and are not suitable for diffuse or tortuous arteries, while alternative methods like atherectomy have not gained widespread success due to their own limitations.

Innovation Solution

A catheter system with a radially expandable balloon and electrodes that uses RF, microwave, or ultrasound energy to gently heat and remodel tissues, avoiding extreme dilation and the need for stenting, thereby remodeling lumens without significant trauma or complexity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If stenting and balloon angioplasty are used to treat atherosclerotic plaque, then the blood vessel is opened and blood flow is improved, but tissue trauma is caused and restenosis occurs

Engineering Contradiction:

Improveblood flow restorationVSAvoidtissue trauma

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical trauma of balloon dilation and stent insertion with thermal energy (RF, microwave, or ultrasound) to remodel atherosclerotic plaque. The energy is delivered through a catheter-based system that heats the plaque tissue to controlled temperatures, causing remodeling without the mechanical injury associated with traditional angioplasty and stenting methods.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Area of stationary object

If traditional balloon dilation is used to open occluded blood vessels, then the vessel lumen is enlarged, but significant tissue injury is imposed

Engineering Contradiction:

Improvevessel lumen areaVSAvoidtissue injury

Core Design Contradiction:

Area of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physical state and properties of atherosclerotic plaque through controlled thermal heating. By delivering RF, microwave, or ultrasound energy, the plaque tissue undergoes temperature-dependent remodeling, transitioning from a rigid, occlusive state to a softened, remodelable state that allows lumen enlargement without mechanical trauma.

Inventive Principle:

Principle #35Parameter changes

3Duration of action of stationary object

If stents are implanted to maintain vessel opening, then the beneficial effect is extended, but mechanical fatigue and corrosion risks are introduced

Engineering Contradiction:

Improvevessel opening durationVSAvoidimplant reliability

Core Design Contradiction:

Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent extracts and removes the need for permanent metal implants by using energy-based plaque remodeling. Instead of inserting stents to maintain vessel patency, the system delivers thermal energy to modify the plaque itself, allowing the vessel to remain open through tissue remodeling without introducing foreign bodies that would be subject to mechanical fatigue and corrosion.

Inventive Principle:

Principle #2Taking out (Extraction)

4Loss of substance

If atherectomy devices are used to remove plaque, then the occlusion is reduced, but the procedure has not gained widespread success due to limitations

Engineering Contradiction:

Improveplaque removalVSAvoidprocedure adaptability

Core Design Contradiction:

Loss of substanceVSAdaptability or versatility

Solution Approach 1:

The patent replaces mechanical plaque removal (atherectomy) with thermal energy delivery. Instead of physically cutting or shaving plaque with rotating blades or cutting balloons, the system uses RF, microwave, or ultrasound energy to heat and remodel plaque in situ, offering a more versatile approach that can treat various plaque types and vessel configurations without the mechanical limitations of atherectomy devices.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 plaques by heating tissues to controlled temperatures, reducing restenosis risk, and improving blood flow without the need for stenting, particularly in cases where stenting is not viable, such as diffuse or tortuous arteries.

Implementation Method 1

A plurality of electrodes are disposed about the expandable member... and heating the remodeling zones in the tissue with the energized electrodes

Methodology Applied

Scientific EffectRF energy heating: Electromagnetic Induction

Implementation Method 2

The expandable member has a low profile insertion configuration and a larger profile configuration... energy intended to remodel the tissue is transmitted between the electrodes and the tissue

Methodology Applied

Scientific EffectMicrowave heating: Microwave Radiation

Implementation Method 3

The structures of the invention allow remodeling body tissue using heat

Methodology Applied

Scientific EffectUltrasound heating: Ultrasonic Vibration

Data Source

PatentUS12161392B2System for inducing desirable temperature effects on body tissue

Publication Date: 2024.12.10 BOSTON SCIENTIFIC SCIMED INC

AI summary

A catheter and catheter system may be used to treat disease tissue by gentle heating in combination with gentle or standard dilation. An elongate flexible catheter body with a radially expandable balloon having a plurality of electrodes engage tissue including diseased tissue when the structure expands.