Prosthetic Heart Valve Frame Anti-Migration Spikes

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Solution Overview

Problem

Existing transcatheter heart valve prostheses face challenges in balancing valve-frame integration and mechanical performance, where reinforcing the valve to the frame can hinder mechanical performance, and there is a need to prevent migration of the valve prosthesis within the vessel after deployment.

Innovation Solution

A valve prosthesis with a stent structure coupled to a prosthetic valve, featuring an inflow portion with anti-migration spikes that protrude radially outward and inward, an hour-glass shape, and reinforcement mechanisms such as valve reinforcement sutures and collagen bonding, which also includes a self-expanding stent structure and buffer nets to reduce contact damage and enhance sealing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the valve is reinforced to the frame at certain locations, then the valve-frame integration is improved, but the mechanical performance of the frame is hindered

Engineering Contradiction:
Improvevalve-frame integrationVSAvoidmechanical performance of frame
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies local quality by providing reinforcement structures (such as reinforcement members, sutures, or adhesive bonding) at specific locations on the valve prosthesis where attachment to the frame is needed, rather than uniformly reinforcing the entire valve. This localized approach strengthens the valve-frame integration at critical points while preserving the overall mechanical performance and flexibility of the frame structure.

Inventive Principle:
Principle #3Local quality

2Stability of the object's composition

If the stent structure is expanded to hold the valve prosthesis firmly in place, then the anchoring capability is improved, but the risk of migration increases

Engineering Contradiction:
Improveanchoring capabilityVSAvoidmigration prevention
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent incorporates anti-migration spikes that protrude radially outward from the inflow portion of the stent structure before deployment. These spikes are pre-positioned to engage with the native valve annulus or surrounding tissue upon expansion, creating preliminary anchoring action that prevents migration. The spikes are designed to be compressed during delivery and then expand to their functional configuration when the stent is deployed, providing immediate migration resistance.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If the anti-migration spikes protrude radially outward from the inflow portion, then the migration prevention is improved, but the contact damage to surrounding tissue may increase

Engineering Contradiction:
Improvemigration preventionVSAvoidcontact damage to surrounding tissue
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent designs the anti-migration spikes with specific geometric parameters including controlled length, diameter, and curvature radius. By optimizing these parameters, the spikes provide sufficient radial protrusion to engage with the native valve annulus and prevent migration, while maintaining a profile that minimizes traumatic contact with surrounding tissue. The spikes are engineered to balance penetration depth with tissue preservation.

Inventive Principle:
Principle #35Parameter changes

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 solution effectively minimizes migration of the valve prosthesis, maintains mechanical performance, and reduces stress and damage during valve operation, thereby improving the durability and sealing capabilities of the transcatheter heart valve.

Implementation Method 1

a self-expanding stent structure

Methodology Applied
Scientific EffectElastic memory: Elasticity

Implementation Method 2

collagen bonding

Methodology Applied
Scientific EffectCollagen bonding: Adhesive

Data Source

PatentEP4385461A1Prosthetic heart valve frame structure
Publication Date: 2024.06.19 MEDTRONIC VASCULAR INC
  • EP4385461A1 patent drawingFigure 1~2
  • EP4385461A1 patent drawingFigure 3
  • EP4385461A1 patent drawingFigure 4~5

AI summary

The techniques of this disclosure generally relate to a valve prosthesis having a prosthetic valve, a stent structure, and anti-migration spikes. The stent structure is coupled to the prosthetic valve and includes an inflow portion. The anti-migration spikes are attached to the inflow portion, the anti-migration spikes protruding radially outward and in an outflow direction from the inflow portion. The anti-migration spikes penetrate into tissue of the vessel, e.g., the aortic annulus of a patient's left ventricle, to prevent migration, i.e., undesirable movement, of the valve prosthesis within the vessel after deployment.