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
Engineering 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
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.
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
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.
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
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.
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
Implementation Method 2
collagen bonding
Data Source
Figure 1~2
Figure 3
Figure 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.