Heart Valve Prosthesis Anchoring and Sealing Mechanism
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Solution Overview
Problem
Minimally invasive percutaneous heart valve replacement methods often result in paravalvular leakage due to incomplete conformance of the stent frame with calcified or diseased native leaflets, leading to significant pressure gradients and blood leakage between the implanted prosthetic valve and native tissue.
Innovation Solution
A heart valve prosthesis with a tubular stent and prosthetic valve component, featuring elements for positioning and sealing that transform from a compressed configuration to a deployed state, utilizing U-shaped or V-shaped support arms that extend and bend radially to securely anchor and seal the prosthesis within the native valve, minimizing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a stent frame is used to support the prosthetic valve, then the valve can be delivered percutaneously and deployed in place, but paravalvular leakage occurs due to incomplete conformance with calcified or diseased native leaflets
Solution Approach 1:
The stent frame is divided into multiple segments or sections, each capable of independent radial expansion. This segmentation allows different portions of the stent to adapt to irregularities in the native valve anatomy, improving conformance and reducing paravalvular leakage while maintaining the overall structural integrity needed for percutaneous delivery
Solution Approach 2:
The stent frame incorporates dynamic elements that allow it to transition from a compressed delivery state to an expanded deployed state. This dynamic transformation enables the stent to conform to the native valve geometry after implantation, addressing the sealing performance issue while preserving the minimally invasive delivery approach
2Stability of the object's composition
If the stent frame is expanded to hold the prosthetic valve firmly in place, then positioning and anchoring are improved, but pressure gradients increase due to gaps between the prosthesis and native tissue
Solution Approach 1:
The stent frame incorporates zones with different radial forces or compliance characteristics. Areas with calcified or diseased leaflets receive enhanced conforming capability through locally adjusted stent properties, allowing better apposition and reduced pressure gradients in critical sealing regions while maintaining overall positioning stability
3Ease of operation
If minimally invasive percutaneous replacement is performed without physical removal of the diseased valve, then the procedure is less invasive, but paravalvular leakage results from incomplete conformance
Solution Approach 1:
The stent frame is designed to accommodate and work with the existing native valve structure rather than requiring its complete removal. By transforming the presence of calcified or diseased leaflets from a barrier to conformance into a guide for stent positioning and expansion, the design achieves sealing without necessitating invasive valve removal
Solution Approach 2:
The stent frame utilizes material properties and structural parameters that enable it to deform and conform to irregular native valve surfaces. Changes in radial compliance, expansion pressure, and frame geometry allow the stent to adapt to the specific anatomy encountered, reducing leakage while maintaining the minimally invasive approach
Data Source
AI summary
A heart valve prosthesis configured for deployment within a native heart valve. The heart valve prosthesis includes a tubular stent and a prosthetic valve component disposed within and secured to the stent. In addition, one or more elements are coupled to a distal end of the stent to position, anchor, and/or seal the prosthesis within the native heart valve. Each element transforms from a compressed configuration in which the elements distally extend from the distal end of the stent to a deployed configuration in which the elements proximally extend from the distal end of the stent. Each element includes at least one U-shaped or V-shaped support arm that bends radially outward and then towards an outer surface of the stent such that it translates more than ninety degrees from the compressed configuration. Each element may include an outer support arm and an inner support arm.


