Rhenium Alloy Expandable Frame for Prosthetic Heart Valve
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Solution Overview
Problem
Current prosthetic heart valves face complications such as vascular injuries, mispositioning, paravalvular leaks, and allergic reactions due to large delivery profiles, material limitations, and geometric issues, which lead to increased risks of embolization, thrombosis, and reduced durability.
Innovation Solution
A prosthetic heart valve with an expandable frame made from a rhenium-containing metal alloy, featuring an open cell geometry and high radial strength, which reduces delivery system size, minimizes recoil, and ensures accurate placement, thereby decreasing vascular complications and improving hemodynamic performance while eliminating nickel content to prevent allergic reactions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a large delivery profile is used to ensure adequate radial strength, then the valve can be deployed, but vascular injuries and neurological complications increase
Solution Approach 1:
The patent changes the material parameters by using a rhenium-containing metal alloy instead of traditional CoCr or NiTi alloys. This material substitution enables the frame to achieve adequate radial strength at a smaller diameter, thereby reducing the delivery profile size and minimizing vascular and neurological complications while maintaining deployment capability
Solution Approach 2:
The patent employs a composite material approach by incorporating rhenium into the metal alloy composition. This composite material strategy allows the frame to achieve superior strength-to-weight ratio and radial strength characteristics, enabling smaller delivery profile while maintaining structural integrity for valve deployment
2Ease of manufacture
If traditional CoCr or NiTi alloys are used for the frame, then manufacturing is established, but nickel content causes allergic reactions
Solution Approach 1:
The patent changes the material composition parameters by replacing traditional NiTi or CoCr alloys with a rhenium-containing metal alloy. This parameter change eliminates nickel content that causes allergic reactions while maintaining manufacturing feasibility through established metal alloy fabrication processes
Solution Approach 2:
The patent applies local quality by selectively removing nickel from the alloy composition while maintaining other necessary metallic properties. This localized compositional modification (removing harmful nickel while keeping rhenium and other metals) eliminates allergic reactions without compromising the frame's structural functionality
3Ease of operation
If the frame is crimped onto a catheter for insertion, then delivery is enabled, but crimp-induced leaflet damage occurs
Solution Approach 1:
The patent changes the mechanical parameters of the frame material by using a rhenium-containing alloy with superior elasticity and ductility. These parameter changes allow the frame to be crimped to smaller diameters without inducing damage to the leaflets, while still enabling successful delivery through the catheter system
Solution Approach 2:
The patent applies beforehand cushioning by selecting a rhenium-containing metal alloy that inherently provides shock absorption and stress distribution during the crimping and deployment process. This material property cushions against mechanical damage to the leaflets during delivery and expansion, preventing crimp-induced injury
4Strength
If balloon expansion is used to deploy the frame, then the valve is opened, but conduction system injury increases
Solution Approach 1:
The patent changes the expansion parameters by using a rhenium-containing metal alloy that enables self-expansion or expansion at lower pressures. This parameter change reduces the balloon inflation diameter and pressure required for frame deployment, thereby minimizing injury to the conduction system while achieving adequate frame expansion
Data Source
AI summary
A prosthetic heart valve for the treatment of structural heart disease wherein the prosthetic heart valve includes an expandable frame that is formed of a rhenium containing metal alloy. The novel geometry of the expandable frame in combination with the frame being partially or fully formed of the rhenium containing alloy enables the formation of a frame that a) has an open cell geometry in the frame of the prosthetic heart valve that can be used to reduce delivery system size, b) has high radial strength, c) has improved restoration of the physiologic EOA, d) has lower recoil, e) has little or no longitudinal foreshortening, f) allows for proper placement of the bioprosthetic valve in relation to the native commissures of the valve, h) has symmetrical and cylindrical expansion of the prosthetic valve resulting in lower rates of leaflet thrombosis and structural valve deterioration, and i) prevents allergic response and restenosis associated with nickel content.