Artificial Valve Prosthesis Free Leaflet Slits Thrombus Prevention

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Solution Overview

Problem

Existing artificial valve prostheses for treating venous valve insufficiency face challenges such as thrombus formation and leaflet material thickening, leading to reduced flexibility and valve performance, particularly when in contact with the vessel wall, and have not been widely adopted due to these issues.

Innovation Solution

A self-expanding or expandable artificial valve prosthesis with a frame and leaflets, where the leaflets have slits extending from the proximal edge, allowing for antegrade flow while restricting retrograde flow, and are made from biocompatible materials like polyurethane and small intestinal submucosa, with a bioactive material for enhanced performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If prosthetic valves are placed using traditional surgical procedures, then valve replacement can be performed, but the procedure requires open surgery with obvious disadvantages

Engineering Contradiction:

Improvevalve replacement effectivenessVSAvoidsurgical invasiveness

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The valve prosthesis is divided into separate components: a collapsible cage structure and a valve member, allowing the valve to be delivered in a compressed state through minimally invasive access and then expanded to its functional configuration at the implantation site

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The valve prosthesis transitions from a collapsed, low-profile delivery configuration to an expanded, functional configuration after implantation, enabling minimally invasive delivery while maintaining full valve functionality

Inventive Principle:

Principle #15Dynamics

2Ease of operation

If valve leaflets are made from SIS or other non-synthetic materials, then the valve provides good initial flexibility, but the leaflet material thickens over time, particularly in regions where the leaflet is in contact with the vessel wall

Engineering Contradiction:

Improveleaflet flexibilityVSAvoidleaflet durability

Core Design Contradiction:

Ease of operationVSDuration of action of moving object

Solution Approach 1:

The valve leaflet is constructed with a composite structure where only the free edge portion contacts the vessel wall, while the attached portion remains anchored to the cage structure, localizing wall contact to a minimal area to reduce thickening

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The valve combines SIS or non-synthetic leaflet material with a synthetic or non-biodegradable cage structure, creating a composite device that leverages the flexibility of natural materials while providing the structural stability and thromboresistance of synthetic materials

Inventive Principle:

Principle #40Composite materials

3Strength

If valve leaflets are made from synthetic or polymer materials, then the valve provides structural stability, but the valve may become less flexible due to excess tissue growth, particularly within the valve pockets

Engineering Contradiction:

Improvevalve structural stabilityVSAvoidvalve flexibility

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The synthetic or polymer material is used specifically for the cage structure providing structural stability, while the valve leaflets are made from SIS or non-synthetic materials that maintain flexibility and resist tissue growth

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The valve combines synthetic cage structure with non-synthetic leaflet material, creating a composite device that leverages the structural stability of synthetic materials while maintaining the flexibility and biocompatibility of natural materials

Inventive Principle:

Principle #40Composite materials

4Reliability

If traditional prosthetic valves are used, then valve function can be provided, but thrombus formation occurs, particularly within the valve pockets where low fluid flow rates can result in pooling

Engineering Contradiction:

Improvevalve functionVSAvoidthrombus formation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Instead of attempting to prevent thrombus formation through coatings or surface modifications, the design inverts the approach by creating a valve structure with minimal pockets and smooth transitions that promote continuous blood flow and eliminate stagnation zones where thrombus could form

Inventive Principle:

Principle #13The other way round (Inversion)

Data Source

PatentUS8679175B2Artificial valve prosthesis with a free leaflet portion

Publication Date: 2014.03.25 COOK MEDICAL TECHNOLOGIES LLC

AI summary

One embodiment of the present invention provides an implantable valve prosthesis. The valve prosthesis includes a frame defining a lumen extending between a proximal frame end and a distal frame end along a longitudinal axis, and a first valve leaflet positioned within the lumen and having a distal edge attached to the frame and a proximal edge free of the frame. The first valve leaflet comprises a first and a second slit extend distally from the proximal edge and defining a free portion of the first valve leaflet between the first and second slits. The first valve leaflet is movable between a first position that allows fluid flow in a first, antegrade, direction and a second position that restricts flow in a second, retrograde direction.