Subintimal Endovascular Devices for Chronic Total Occlusion Crossing

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Solution Overview

Problem

Existing endovascular devices struggle with inefficiency, high risk of vessel perforation, and inability to effectively cross chronic total occlusions, posing significant health risks and necessitating invasive bypass surgery.

Innovation Solution

The use of subintimal devices to guide conventional devices through the vessel lumen, delaminate vessel wall layers, and remove tissues from occlusive lesions, facilitated by fluid infusion and mechanical means to establish a delamination plane and navigate through the subintimal space.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional endovascular devices are used to cross chronic total occlusions, then the procedure may be simpler to perform, but the devices fail to cross the occlusion (poor efficacy)

Engineering Contradiction:

Improveability to cross occlusionVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into multiple functional segments: a guide catheter for navigation, a subintimal device for creating the dissection plane, and a second device for delivering treatment. This segmentation allows each component to perform its specific function effectively, enabling crossing of chronic total occlusions that single devices cannot penetrate.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The subintimal device acts as an intermediary element that creates a controlled dissection plane between the intima and media layers. This intermediate pathway allows subsequent devices to cross the occlusion by traveling through the subintimal space rather than attempting to force through the dense occlusive material directly.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If conventional endovascular devices are used, then the procedure may be less complex, but the risk of perforating a vessel increases (poor safety)

Engineering Contradiction:

Improvevessel safetyVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The guide catheter is positioned proximal to the occlusion before the subintimal device is advanced. This pre-positioning creates a protective barrier and controlled environment that cushions the vessel wall against accidental perforation during the dissection process, allowing safe navigation through the occlusion.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The subintimal device creates a controlled intermediate dissection plane that separates the intima from the media layers. This controlled separation prevents uncontrolled vessel wall damage and perforation by providing a defined pathway through the occlusion that protects the vessel integrity.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If more invasive bypass surgery is performed, then the occlusion can be reliably bypassed, but the invasiveness and recovery time increase

Engineering Contradiction:

Improveocclusion treatment effectivenessVSAvoidinvasiveness

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The procedure extracts or removes the occlusive material from the vessel by delivering atherectomy devices, stents, or other treatment modalities through the subintimal pathway. This allows the occlusion to be cleared or bypassed endovascularly rather than requiring open surgical bypass, reducing invasiveness while maintaining effectiveness.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention replaces the mechanical open surgical bypass system with an endovascular approach using catheter-based devices. Instead of external surgical incisions and grafts, the treatment is delivered through percutaneous catheter access, substituting a less invasive mechanical system for the traditional surgical approach.

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

Enhances the ability to safely and efficiently cross chronic total occlusions, reducing the risk of vessel perforation and enabling less invasive treatments for conditions like coronary and peripheral artery occlusions.

Implementation Method 1

Fluid infusion may serve to apply a hydraulic pressure to the tissues and aid in layer delamination

Methodology Applied

Scientific EffectHydraulic pressure: Pressure Increase

Implementation Method 2

a subintimal device may be used to delaminate the connective tissues between layers within the lesion or vessel wall

Methodology Applied

Scientific EffectMechanical force: Mechanical Force

Implementation Method 3

or remove tissues from the chronic total occlusion or surrounding vessel

Methodology Applied

Scientific EffectMechanical removal: Mechanical Force

Data Source

PatentUS12458391B2Endovascular devices and methods

Publication Date: 2025.11.04 BOSTON SCIENTIFIC SCIMED INC

AI summary

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing an intravascular device having a distal portion with a side port, inserting the device into the vascular lumen, positioning the distal portion in the vascular wall, directing the distal portion within the vascular wall such that the distal portion moves at least partially laterally, and directing the side port towards the vascular lumen.