Vascular Filter Deflector for Stroke Prevention

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Solution Overview

Problem

Current methods for preventing embolic material from entering the cerebral vasculature during endovascular procedures are inadequate, leading to high stroke rates due to exposure of critical arteries, particularly the left vertebral artery, which provides 10% of cerebral blood supply, resulting in potential stroke risks of up to 20%.

Innovation Solution

A vascular filter and deflector assembly is positioned in the left subclavian artery upstream of the left vertebral artery, comprising a self-expanding filter assembly and a deflector assembly deployable from an outer sheath, which captures embolic material and prevents its entry into the cerebral vasculature, reducing stroke risk by inhibiting embolic material from entering through the left vertebral artery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If percutaneous aortic valve replacement procedures are performed, then valve replacement is achieved, but stroke rates increase to between four and twenty percent due to embolic material entering cerebral circulation

Engineering Contradiction:

Improvestroke preventionVSAvoidembolic material exposure

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The filter assembly is deployed in the left subclavian artery upstream of the left vertebral artery before the endovascular procedure begins. This preliminary placement captures embolic material before it can enter the cerebral circulation, preventing stroke while allowing the valve replacement procedure to proceed.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The filter assembly acts as an intermediary device between the aortic valve and the cerebral circulation. It intercepts embolic material generated during valve replacement and prevents its downstream migration to the brain, thus mediating the harmful effect of embolic exposure.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the left vertebral artery is exposed during endovascular procedures, then procedural access is maintained, but stroke risk increases due to potential embolic material entry

Engineering Contradiction:

Improveprocedural accessVSAvoidcerebral embolism risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The protection strategy segments the cerebral circulation protection by specifically targeting the left vertebral artery pathway. Rather than attempting to protect all cerebral arteries simultaneously, the filter is placed selectively in the left subclavian artery to protect the left vertebral artery, which provides 10% of cerebral blood supply.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The filter assembly provides localized protection specifically at the left subclavian artery where the left vertebral artery originates. This local placement captures embolic material destined for the left vertebral artery without interfering with access to other vessels or the overall procedural approach.

Inventive Principle:

Principle #3Local quality

3Reliability

If a vascular filter assembly is deployed to protect the left vertebral artery, then stroke risk is reduced to less than 1%, but device complexity increases

Engineering Contradiction:

Improvestroke prevention efficacyVSAvoidfilter assembly structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The filter assembly is nested within a delivery catheter system that allows percutaneous access. The filter is contained within the catheter during delivery and deployment, then self-expands to its functional configuration. This nesting enables a relatively complex filter structure to be delivered through a minimally invasive approach.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The filter assembly is designed to self-expand upon deployment from the catheter. The mechanical structure automatically transitions from a compressed delivery state to an expanded functional state without requiring external manipulation, simplifying the deployment process despite the device's structural complexity.

Inventive Principle:

Principle #25Self-service

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 solution significantly reduces the risk of stroke by effectively capturing embolic material and preventing its entry into the cerebral vasculature, with stroke rates reduced to less than 1% when the left vertebral artery is protected, compared to higher rates without embolic protection.

Implementation Method 1

A blood filtering assembly can capture embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Implementation Method 2

The distal portion of the protection device comprises an outer sheath, an inner member radially inward of the outer sheath, and a self-expanding filter assembly radially between the outer sheath and the inner member

Methodology Applied

Scientific EffectElastic recovery: Elastic Recovery

Data Source

PatentUS10449028B2Vascular filters, deflectors, and methods

Publication Date: 2019.10.22 BOSTON SCIENTIFIC SCIMED INC

AI summary

Vascular filters and deflectors and methods for filtering bodily fluids. A blood filtering assembly can capture embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature. A blood deflecting assembly can deflect embolic material dislodged or generated during an endovascular procedure to inhibit or prevent the material from entering the cerebral vasculature.