Introducer sheath with embolic protection

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Solution Overview

Problem

Current embolic protection devices are cumbersome and limit simultaneous access to the aortic valve during cardiac procedures, as they allow only a single catheter to pass through and restrict the size of catheters that can be used, posing risks for emboli release into cerebral vasculature.

Innovation Solution

An embolic protection device with an embolic filter and inner sheath that allows simultaneous access by multiple catheters through expandable ports, enabling the device to be placed over the aortic arch to capture emboli while allowing at least two catheters to access the aortic valve, with a porous mesh material and self-expanding framework for deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a single catheter is allowed to pass through the embolic filter, then embolic protection is provided, but simultaneous access to the aortic valve by multiple catheters is limited

Engineering Contradiction:
Improveembolic protectionVSAvoidsimultaneous catheter access
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The embolic filter is divided into multiple independent ports, each capable of accepting a catheter simultaneously. The filter body is segmented into distinct access pathways that maintain embolic protection while allowing multiple catheters to pass through different ports at the same time.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheters are nested within the filter structure, passing through the filter body from the aortic side to the ventricular side. The filter encompasses multiple catheters within its structure, allowing simultaneous access while maintaining protection.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If the sheath dimensions are reduced to allow catheter passage, then access is enabled, but the size of catheter that can be introduced is limited

Engineering Contradiction:
Improvecatheter introductionVSAvoidcatheter size accommodation
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The filter ports are designed to be dynamic in size, capable of expanding to accommodate different catheter diameters. The filter material or structure allows elastic deformation or mechanical expansion to adapt to various catheter sizes while maintaining embolic protection functionality.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The physical parameters of the filter ports (size, shape, flexibility) are changed to accommodate different catheter specifications. The filter can alter its dimensional parameters to allow passage of various catheter sizes without compromising its protective function.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If multiple access paths are used to reach the aortic valve, then catheter access is enabled, but the procedure becomes more complex and injury-prone

Engineering Contradiction:
Improvecatheter accessVSAvoidaccess procedure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The embolic filter serves multiple functions simultaneously: it provides embolic protection, enables multiple catheter access paths, and maintains a relatively simple single-access-point procedure. The device combines protective and access-enabling functions in a single structure.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The embolic filter acts as an intermediary structure between the aortic arch and the aortic valve, providing a controlled passage point that simplifies the access procedure while maintaining protection. Instead of requiring multiple separate access points, the filter mediates all catheter passages through a single deployed structure.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 device effectively prevents emboli release into cerebral vasculature during procedures like aortic valve replacement, allowing simultaneous catheter access and accommodating various catheter sizes, thereby improving procedural outcomes and reducing complications.

Implementation Method 1

an embolic filter and inner sheath that allows simultaneous access by multiple catheters through expandable ports, enabling the device to be placed over the aortic arch to capture emboli

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 2

a porous mesh material and self-expanding framework for deployment

Methodology Applied
Scientific EffectElastic expansion: Elastic Recovery

Data Source

PatentUS9877821B2Introducer sheath with embolic protection
Publication Date: 2018.01.30 EMBOLINE
  • US9877821B2 patent drawing
  • US9877821B2 patent drawing
  • US9877821B2 patent drawing

AI summary

The embolic protection device comprises an embolic filter attached to an inner sheath. The embolic filter includes at least a first catheter access port and a second catheter port. At least the first catheter port will typically be radially expandable to receive catheters of different diameters and will be located at an atypical end of an aero conical structure at a downstream end of the filter.