Self-Expanding Scaffold for Stroke Clot Maceration

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Solution Overview

Problem

Current methods for treating acute ischemic stroke lack effective solutions for immediate blood flow restoration and in-situ clot management, often resulting in neuronal destruction and the risk of distal embolization during clot removal.

Innovation Solution

The development of a thrombus management method involving a self-expanding scaffold deployed within a microcatheter to compress and macerate clots, facilitating natural lysis and fragmentation while allowing embolic particles to be lysed by restored blood flow, without the need for distal embolic protection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Speed

If clot removal methods are used to restore blood flow, then blood flow restoration is achieved, but distal embolization risk increases

Engineering Contradiction:

Improveblood flow restoration speedVSAvoiddistal embolization risk

Core Design Contradiction:

SpeedVSObject-affected harmful factors

Solution Approach 1:

The patent converts the harmful effect of clot fragmentation into a beneficial process by allowing controlled maceration of the clot into small particles that can be naturally lysed and cleared by the body's fibrinolytic system, rather than causing dangerous distal embolization. The scaffold structure facilitates this by providing a framework for controlled clot breakdown while maintaining local containment.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The self-expanding scaffold acts as an intermediary structure between the clot and the blood flow. It provides mechanical compression to macerate the clot while simultaneously serving as a filter and framework that prevents embolic particles from entering the distal circulation, allowing blood flow restoration without the harmful effects of direct clot removal.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If mechanical clot removal is performed, then clot removal efficiency is improved, but neuronal damage increases due to procedural time and manipulation

Engineering Contradiction:

Improveclot removal efficiencyVSAvoidneuronal damage

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent employs the body's own fibrinolytic system to clear the macerated clot particles rather than requiring complete mechanical removal. The scaffold structure and restored blood flow enable the body's natural enzymes to dissolve and clear the debris, reducing procedural manipulation time and associated neuronal damage while maintaining efficient clot clearance.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The scaffold is deployed in advance to establish the structural framework and restore blood flow before complete clot clearance occurs. This preliminary action allows time for natural lysis to begin while the scaffold maintains vessel patency, reducing the urgency for aggressive mechanical removal that could cause neuronal damage.

Inventive Principle:

Principle #10Preliminary action

3Object-affected harmful factors

If distal embolic protection devices are used, then distal embolization risk is reduced, but device complexity and procedural difficulty increase

Engineering Contradiction:

Improvedistal embolization riskVSAvoidprocedural complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The self-expanding scaffold performs multiple functions simultaneously: it restores blood flow through mechanical compression, macerates the clot into manageable particles, filters embolic debris, and provides a framework for natural lysis. This multi-functionality eliminates the need for separate distal embolic protection devices, reducing overall procedural complexity while maintaining safety.

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 rapid restoration of blood flow, reduces neuronal damage, and minimizes the risk of distal embolization by allowing embolic particles to be naturally lysed, thereby improving treatment efficacy and safety in acute ischemic stroke management.

Implementation Method 1

deploying the reperfusion device within the thrombus compresses the thrombus against an inner wall of the blood vessel, thereby restoring blood flow

Methodology Applied

Scientific EffectMechanical compression: Compression

Implementation Method 2

restored blood flow facilitates natural lysis of the thrombus

Methodology Applied

Scientific EffectNatural lysis: Hydrolysis

Data Source

PatentUS11786254B2Methods of managing neurovascular obstructions

Publication Date: 2023.10.17 COVIDIEN LP

AI summary

Systems, methods, and devices for the treatment of acute ischemic stroke that provide immediate blood flow restoration to a vessel occluded by a clot and, after reestablishing blood flow, address the clot itself Immediate blood flow restoration advantageously can facilitate natural lysis of the clot and also can reduce or obviate the concern for distal embolization due to fragmentation of the clot. Several embodiments of the invention provide for progressive, or modular, treatment based upon the nature of the clot. For example, the progressive treatment can include immediate restoration of blood flow, in-situ clot management, and/or clot removal depending on the particular circumstances of the treatment. The in-situ clot management can include, for example, lysis, maceration, and/or removal.