Atherectomy Device Orientation via OCT Crescent Morphology

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Solution Overview

Problem

Current atherectomy devices face challenges in precisely orienting and navigating interventional devices within coronary arteries due to the eccentric nature of atherogenesis, often relying on inadequate visualization methods like angiography, which can lead to vessel damage and ineffective treatment.

Innovation Solution

The method involves applying circumferential radial force to displace plaque masses, imaging with optical coherence tomography (OCT) to identify crescent-shaped structures, and using these morphological features to orient and position atherectomy devices accurately within the vessel, ensuring precise targeting of diseased tissue while avoiding healthy vessel walls.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If angiography is used for visualization, then the silhouette of the open lumen can be obtained, but the precision of device orientation and tissue characterization is insufficient

Engineering Contradiction:
Improvevisualization precisionVSAvoidtissue characterization information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The patent replaces the mechanical/physical limitation of angiography (which only provides 2D silhouette) with Optical Coherence Tomography (OCT) imaging technology. OCT uses light waves to generate high-resolution cross-sectional images of the vessel wall and plaque, providing both precise spatial orientation and detailed tissue characterization without the information loss inherent in conventional angiography.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent employs a composite imaging approach by combining OCT imaging with atherectomy device functionality. The OCT catheter integrates imaging sensors, light sources, and signal processing components within a single device platform, enabling simultaneous high-resolution imaging and therapeutic intervention, thereby achieving both precise visualization and effective treatment in one system.

Inventive Principle:
Principle #40Composite materials

2Ease of operation

If the active element acts equally in all directions, then the device can be operated without complex orientation, but the device must reside in the center of the diseased portion which is difficult to achieve with eccentric atherogenesis

Engineering Contradiction:
Improvedevice operation simplicityVSAvoiddevice positioning precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent transitions from isotropic (equal in all directions) cutting action to anisotropic (directional) cutting action. The atherectomy device is designed with a directional active element that can be precisely oriented using OCT imaging guidance. This allows the cutting element to selectively remove plaque from specific locations within the vessel wall, matching the eccentric distribution of atheroma and improving treatment precision while maintaining operational feasibility through real-time imaging feedback.

Inventive Principle:
Principle #3Local quality

3Productivity

If guidewire is placed through the occlusion, then the atherectomy can be performed, but the guidewire may direct out of the lumen into the adventitia and surrounding tissues causing vessel damage

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidvessel damage risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent implements real-time OCT imaging feedback during the entire procedure, including guidewire placement and atherectomy. The OCT system continuously monitors the position of the guidewire and atherectomy device relative to the vessel wall, providing immediate visual feedback to the operator. This allows detection of potential perforation risks before they occur, enabling corrective action and preventing vessel damage while maintaining treatment effectiveness.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent performs preliminary OCT imaging assessment before guidewire placement to identify the precise location and characteristics of the occlusion and surrounding vessel wall. This preliminary visualization allows planning of the safest approach path for guidewire insertion, avoiding vulnerable areas and reducing the risk of inadvertent vessel perforation during the subsequent atherectomy procedure.

Inventive Principle:
Principle #10Preliminary action

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 enables consistent and precise orientation of atherectomy devices, reducing the risk of vessel perforation and improving the effectiveness of plaque removal by utilizing characteristic crescent-shaped morphologies visible through OCT imaging, facilitating safer and more accurate interventional procedures.

Implementation Method 1

imaging with optical coherence tomography (OCT) to identify crescent-shaped structures

Methodology Applied
Scientific EffectOptical coherence tomography: Tomography

Data Source

PatentEP2775945B1Occlusion-crossing devices, atherectomy devices, and imaging
Publication Date: 2019.05.08 AVINGER INC
  • EP2775945B1 patent drawingFigure 1
  • EP2775945B1 patent drawingFigure 2
  • EP2775945B1 patent drawingFigure 3

AI summary

Described herein are methods for producing and identifying characteristic ("crescent shaped") regions indicative of an atherectomy plaque within a vessel, and systems and devices adapted to take advantage of this characteristic region.