Prosthetic Heart Valve Frame Material to Minimize Recoil
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Solution Overview
Problem
Current prosthetic heart valves face complications such as vascular injury, mispositioning, paravalvular leak, thrombosis, conduction system abnormalities, and high nickel content, due to large delivery profiles, recoil, and non-uniform frame expansion, which affect hemodynamic performance and durability.
Innovation Solution
The use of a prosthetic heart valve frame formed partially or fully of rhenium alloy, hafnium alloy, or refractory metal alloys with specific geometries and coatings to reduce delivery system size, improve radial strength, minimize recoil, and enhance alignment with native anatomy, reducing complications and improving longevity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional CoCr or Nitinol frame is used, then the valve can be deployed, but the delivery system has a large profile causing vascular injury and neurological complications
Solution Approach 1:
The patent applies parameter changes by transitioning from traditional CoCr or Nitinol materials to a rhenium-based alloy with fundamentally different material properties. This new alloy enables the frame to achieve the required radial strength at a significantly smaller diameter, thereby reducing the delivery system profile and minimizing vascular and neurological complications during implantation.
Solution Approach 2:
The patent employs composite materials by developing a rhenium-based alloy that combines rhenium with other metals to create a material with superior strength-to-weight ratio and radial strength characteristics. This composite alloy structure allows the frame to maintain structural integrity while achieving a reduced profile for safer delivery.
2Reliability
If the frame is expanded to restore physiological orifice area, then hemodynamic function improves, but frame recoil occurs causing paravalvular leak and embolization
Solution Approach 1:
The patent applies parameter changes by utilizing the unique elastic and plastic deformation characteristics of the rhenium-based alloy. The material's specific mechanical properties allow the frame to expand to the required physiological orifice area and then maintain that expansion stable, preventing the recoil phenomenon that causes paravalvular leak and embolization with traditional materials.
Solution Approach 2:
The patent applies the principle of using a material with specific degradation characteristics - the rhenium-based alloy is designed to undergo controlled plastic deformation during expansion and then maintain its new shape permanently, unlike traditional materials that exhibit elastic recovery (recoil). This permanent deformation capability ensures stable frame position without causing paravalvular leak.
3Ease of operation
If the frame is crimped onto a catheter for insertion, then delivery is enabled, but non-uniform expansion occurs leading to mispositioning and paravalvular leak
Solution Approach 1:
The patent applies parameter changes by exploiting the unique stress-strain behavior of the rhenium-based alloy during crimping and expansion. The material's specific mechanical properties allow for uniform stress distribution throughout the frame structure during crimping, and subsequent uniform expansion during deployment, preventing mispositioning and paravalvular leak while maintaining delivery capability.
4Ease of manufacture
If traditional materials with high nickel content are used, then the frame can be manufactured, but allergic reactions and thrombosis occur
Solution Approach 1:
The patent employs composite materials by replacing traditional nickel-containing alloys (CoCr, Nitinol) with a rhenium-based alloy composition. This new material composition eliminates nickel and other allergenic metals while maintaining or improving manufacturing capabilities through the superior formability and strength characteristics of the rhenium-based material.
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 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/or i) prevents allergic response and restenosis associated with nickel content.