Valve Stent Barb Anchoring for Mitral Valve Stability

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Solution Overview

Problem

Existing valve stents and prostheses for mitral and tricuspid valves face challenges with unstable anchorage due to calcification, leading to insufficient anchoring force and increased risk of valve failure in patients with valvular heart disease.

Innovation Solution

A self-expanding valve stent with a mesh tube design, featuring an inflow tract structure, transition tract structure, and outflow tract structure, along with a barb structure, which includes inwardly recessed sections and barbs to enhance anchoring by fitting within the natural valve annulus and leaflets, reducing the risk of excessive force on the natural valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional valve stents are used for mitral and tricuspid valves, then the procedure can be performed via transcatheter approach, but the anchorage is unstable due to valve calcification and insufficient anchoring force

Engineering Contradiction:
Improveanchorage stabilityVSAvoidanchoring force
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The valve stent is divided into multiple segments including a first stent segment, a second stent segment, and a connection segment. Each segment can be independently expanded and positioned, allowing the barbs on different segments to engage with different portions of the valve annulus and leaflets, thereby distributing and enhancing the overall anchoring force while maintaining stable anchorage.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The valve stent is designed with a nested structure where the first stent segment, second stent segment, and connection segment are arranged in a sequential nested configuration. This allows the stent to be delivered through a catheter in a compressed state and then expanded in situ, enabling the barbs to penetrate and anchor into the valve tissue at multiple levels, thus improving anchorage stability without requiring open surgery.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Strength

If barbs are added to enhance anchoring, then anchoring force increases, but the risk of excessive force on the natural valve increases

Engineering Contradiction:
Improveanchoring forceVSAvoiddamage to natural valve
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The valve stent incorporates barbs with specific local characteristics - the barbs are positioned at specific locations on the stent segments and have optimized dimensions and orientations. This local quality ensures that the anchoring force is concentrated at specific points where it is most effective, while the overall distribution of barbs and the flexible connection segment prevent excessive force from being applied to any single point on the natural valve, thereby reducing the risk of damage.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The connection segment between the first and second stent segments provides dynamic flexibility, allowing the stent to adapt to the natural movement and deformation of the valve during the cardiac cycle. This dynamic design ensures that the barbs maintain effective anchoring force while accommodating physiological motion, preventing excessive static force that could damage the natural valve tissue.

Inventive Principle:
Principle #15Dynamics

3Reliability

If the stent structure is made more complex with multiple segments and barbs, then anchoring stability improves, but the device complexity increases

Engineering Contradiction:
Improveanchorage stabilityVSAvoidstent structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The valve stent merges multiple functions into a single integrated device: the first stent segment, second stent segment, and connection segment are combined into one continuous structure that provides both structural support and anchoring functions. The barbs are integrated directly onto the stent segments rather than being separate components, simplifying the overall device while maintaining enhanced anchorage stability through the multi-segment design.

Inventive Principle:
Principle #5Merging (Combining)

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 design improves anchoring stability and reduces the risk of fatigue failure by distributing the anchoring force more evenly, ensuring secure positioning and function of the valve stent within the natural mitral and tricuspid valves.

Implementation Method 1

The valve stent is a self-expanding stent, is shaped as a mesh tube, and has a compressed state and an expanded state

Methodology Applied
Scientific EffectElastic memory: Elasticity

Data Source

PatentUS11395735B2Valve stent and valve prosthesis
Publication Date: 2022.07.26 SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD
  • US11395735B2 patent drawing
  • US11395735B2 patent drawing
  • US11395735B2 patent drawing

AI summary

A valve stent and a valve prosthesis. The valve stent is in the shape of a mesh tube, and has a compressed state and an expanded state. The valve stent includes an inflow tract structure, a transition tract structure, an outflow tract structure, and a barb structure. The transition tract structure has a fifth end portion, a sixth end portion, and a first middle section. In the expanded state, the diameters of the radial sections of the fifth end portion and the sixth end portion are greater than the diameter of the radial section of the first middle section of the transition tract structure. The outflow tract structure has a seventh end portion and an eighth end portion. The seventh end portion of the outflow tract structure is fixedly connected to the sixth end portion of the transition tract structure, and the eighth end portion is a free end. The barb structure is disposed on the transition tract structure and the outflow tract structure, and protrudes towards the outside of the transition tract structure and/or the outflow tract structure. The valve stent and the valve prosthesis can be stably anchored on natural valves.