Two-Piece Prosthetic Heart Valve Snap-In Connection
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Solution Overview
Problem
The complexity of securing prosthetic heart valves within the heart's annulus, particularly due to mismatched shapes, leads to impaired blood hemodynamics, clotting, and calcification, requiring lengthy cardiopulmonary bypass and increased risk of mistakes during the implantation process.
Innovation Solution
A two-piece prosthetic heart valve assembly with a gasket member and a valve member featuring fasteners and engagement members, where the fasteners are U-shaped spring-biased clips and the engagement members have ramped and blunt edges, guiding secure engagement and preventing removal, facilitating easier and more precise implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sewing rings with multiple sutures are used to secure prosthetic valves, then the valve can be implanted within the annulus, but the procedure becomes complex and time-consuming requiring management of twelve to twenty sutures
Solution Approach 1:
The sewing ring is divided into multiple discrete clips (e.g., three clips spaced around the circumference), each clip serving as an independent fastening unit. This segmentation replaces the continuous suture system with multiple simple mechanical fasteners, reducing procedural complexity while maintaining secure attachment through distributed fastening points
Solution Approach 2:
The clips are designed with self-securing mechanisms including spring-biased arms that automatically engage with the valve frame and release mechanisms that allow easy detachment. The ramped edges guide proper alignment and engagement without requiring manual manipulation of multiple sutures, making the system self-servicing during implantation
2Adaptability or versatility
If flexible sewing rings are distorted to conform to the annulus anatomy, then better anatomical fit is achieved, but the valve and sewing ring may not mate together effectively causing leaks and impaired performance
Solution Approach 1:
The sewing ring with its discrete clips is designed to be flexible and adaptable to non-circular annulus shapes, while the valve frame maintains its structural integrity. The clips can be positioned at optimal locations to accommodate anatomical variations, and the spring-biased design allows dynamic adjustment during engagement, enabling both anatomical conformity and secure mating
Solution Approach 2:
The clips act as intermediary elements between the flexible sewing ring and the rigid valve frame. Each clip provides a localized connection point that transfers forces between the two components, allowing the sewing ring to conform to the annulus while maintaining effective mechanical coupling with the valve through multiple distributed attachment points
3Reliability
If multiple sutures are used to secure the sewing ring, then the valve can be anchored within the annulus, but the procedure requires lengthy cardiopulmonary bypass time
Solution Approach 1:
The complex suture tying and knot-securing process is replaced with simple mechanical clip engagement. The clips use spring-biased arms that snap into place on the valve frame, eliminating the need for manual knot tying and suture manipulation. This mechanical substitution dramatically reduces the time required for secure anchoring while maintaining equivalent or superior fixation reliability
Solution Approach 2:
The clips are pre-assembled on the sewing ring before implantation, with spring-biased arms positioned to automatically engage with the valve frame upon deployment. This preliminary preparation eliminates the need for time-consuming intraoperative assembly and suture management, allowing rapid securement during the surgical procedure
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
This solution simplifies the implantation process, enhances the fit of the prosthetic valve within the annulus, reduces the risk of leaks and calcification, and improves blood flow dynamics by ensuring secure and optimal positioning of the valve.
Implementation Method 1
The fasteners may include U-shaped spring-biased clips
Data Source
AI summary
A prosthetic heart valve assembly includes a gasket member and a valve member including a plurality of fasteners and a plurality of engagement members corresponding to the fasteners. The fasteners and/or engagement members may be configured to guide the engagement members into engagement with the fasteners. For example, the fasteners may include U-shaped spring-biased clips, e.g., attached to a core or other portion of a sewing cuff of the gasket member, and the engagement members may include latches or barbed protrusions that engage one or more holes in the fasteners. During use, the gasket member is introduced into a tissue annulus, and secured to the annulus, e.g., using a plurality of clips directed through the sewing cuff. The valve member is then introduced into the annulus and the engagement members are snapped or otherwise guided into engagement with the fasteners to secure the valve member relative to the gasket member.