U-Shaped Embolic Filter Frames for Continued Blood Flow

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Solution Overview

Problem

Minimally invasive cardiac valve replacement procedures face challenges in preventing embolisms due to the liberation of particulate material and soluble mediators, with existing occlusion and filtering methods posing risks such as shunting and reduced maneuverability, and there is a need for devices that minimize these risks.

Innovation Solution

The development of embolic protection devices comprising a filter frame with U-shaped members and a filter sheet, delivered via antegrade or retrograde methods using sheaths and balloon catheters, to capture debris while maintaining blood flow, utilizing materials like shape memory metals for flexibility and expandability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If occlusion methods are used for embolic protection, then debris evacuation is simplified and convenient, but shunting of debris into side branches occurs and end-organ ischemia is caused

Engineering Contradiction:

Improvedebris evacuation simplicityVSAvoidshunting of debris and end-organ ischemia

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

A distal filter is introduced as an intermediary device between the occlusion site and the distal vascular bed. The filter captures debris in the proximal region while allowing controlled passage through the distal region, preventing direct shunting into side branches and eliminating the need for complete occlusion of the main vessel.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The embolic protection device is segmented into multiple functional regions: a proximal filter region for debris capture and a distal open region for maintained perfusion. This segmentation allows different zones to perform different functions simultaneously, avoiding the need for complete occlusion while still providing effective debris filtration.

Inventive Principle:

Principle #1Segmentation

2Reliability

If distal filtering is used for embolic protection, then ongoing perfusion is maintained, but larger-diameter sheath is required and maneuverability is reduced

Engineering Contradiction:

Improveongoing perfusion maintenanceVSAvoiddevice maneuverability

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The device is divided into a filter portion with larger diameter for debris capture and a guidewire portion with smaller diameter for maneuverability. This segmentation allows the filter to maintain its larger size for effective filtration while the guidewire can be easily maneuvered through the vascular system due to its smaller profile.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device transitions from a two-dimensional planar filter structure to a three-dimensional configuration where the filter portion is expanded radially while the guidewire portion remains flexible and slender. This dimensional transition allows the filter to provide effective debris capture area while maintaining the flexibility needed for vascular navigation.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

3Ease of operation

If percutaneous devices are used for valve replacement, then minimally invasive approach is achieved, but vessel damage occurs and embolism risk increases

Engineering Contradiction:

Improveminimally invasive approachVSAvoidvessel damage and embolism risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The distal filter acts as a protective intermediary that captures debris released during the minimally invasive valve replacement procedure before it can cause embolism. This allows the percutaneous approach to maintain its minimally invasive advantage while the filter mitigates the harmful effects of vessel damage and debris liberation.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The device converts the harmful effect of debris liberation into a beneficial filtration process. By positioning the filter in the distal region, debris that would otherwise cause embolism is captured and retained, transforming the potential harm into a protective mechanism that prevents distal vascular complications.

Inventive Principle:

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

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

These devices effectively reduce the incidence of embolisms by capturing debris during cardiac valve procedures, ensuring minimal vessel damage and increased maneuverability, thereby reducing the risk of stroke and other ischemic events.

Implementation Method 1

a filter sheet

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Implementation Method 2

utilizing materials like shape memory metals for flexibility and expandability

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS12440324B2Embolic protection devices and methods of use

Publication Date: 2025.10.14 JC MEDICAL INC

AI summary

Devices and methods are discussed herein for protection from embolisms and microembolisms in a subject undergoing catheter-based intravascular procedures. The embolic protection devices have an expandable support frame comprising U-shaped members and leg members which facilitate proper placements in a defective valve annulus. The filtering devices expand in the vessels and allow blood flow to continue through the vessels, thereby catching and removing debris of the flowing blood. Also disclosed are embolic protection devices for use with a sutureless valve prosthesis which is implanted via catheter-based methods.