Percutaneous Flow Reversal Sheath for Carotid Embolic Protection

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Solution Overview

Problem

Current methods for reducing embolic risk during carotid artery interventions, such as carotid stenting, either require external flow reversal systems or surgical exposure, which are invasive and carry risks, and lack a system for internal flow reversal from the carotid artery to the jugular vein.

Innovation Solution

A flow reversal sheath with an occlusion balloon and a mesh filter is used to reverse blood flow from the carotid artery to the jugular vein, allowing for internal rerouting of blood flow, minimizing surgical exposure and trauma to the carotid artery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If external flow reversal systems or surgical exposure are used to reduce embolic risk, then embolic protection is improved, but invasiveness and procedural risk increase

Engineering Contradiction:
Improveembolic protectionVSAvoidinvasiveness and procedural risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary device - a sheath with flow reversal capability - that mediates between the carotid artery and jugular vein. This sheath creates an internal flow reversal pathway without requiring external surgical exposure, thus maintaining embolic protection while reducing invasiveness. The sheath acts as a bridge that redirects blood flow internally through the venous system rather than requiring external clamping or surgical intervention.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If traditional embolic protection devices are used via femoral artery access, then embolic material is trapped, but device complexity and procedural time increase

Engineering Contradiction:
Improveembolic protectionVSAvoiddevice and procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sheath device performs multiple functions simultaneously: it provides embolic protection through its filter, enables flow reversal through its design with holes in the distal portion, and facilitates access to the carotid artery through jugular vein puncture. This multi-functionality consolidates what would otherwise require separate devices (embolic filter, flow reversal system) into a single integrated system, reducing overall device complexity and procedural steps.

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 method provides a minimally invasive, interventional approach to prevent embolic events by reversing blood flow internally, reducing procedural risks and allowing non-surgical access to the carotid artery, thus enabling safer and more accessible carotid interventions.

Implementation Method 1

an occlusion balloon positioned proximal to a distal end of the flow reversal sheath and configured to block flow in the carotid artery

Methodology Applied
Scientific EffectBalloon occlusion:

Implementation Method 2

a mesh filter covering at least some of the plurality of holes, the flow reversal region configured to be positioned in the jugular vein

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 3

a flow reversal sheath for reversing flow in the carotid artery... The flow reversal region can be positioned about 5 cm from the distal end of the distal end of the flow reversal sheath

Methodology Applied
Scientific EffectFlow reversal:

Data Source

PatentUS11426173B2Devices and methods using percutaneous transjugular carotid flow reversal
Publication Date: 2022.08.30 PILLAI LAKSHMIKUMAR
  • US11426173B2 patent drawing
  • US11426173B2 patent drawing
  • US11426173B2 patent drawing

AI summary

Methods and devices for performing transjugular carotid flow reversal are provided. A flow reversal sheath is advanced through a transjugular carotid fistula. An occlusion balloon is inflated, causing carotid inflow to be diverted through the sheath and through a flow reversal region positioned in the jugular vein. After reversal of blood flow, a carotid intervention is performed.