Rail-Guided Prosthetic Valve Attachment System
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Solution Overview
Problem
The complexity of securing prosthetic heart valves within the heart's annulus leads to suboptimal fit, impairing blood hemodynamics and increasing the risk of clotting and calcification, due to the mismatch between the annulus and sewing ring or valve circular cross-sections, and the difficulty in securing multiple component valves effectively.
Innovation Solution
A heart valve assembly featuring an annular member with a sewing cuff and rail ring, along with guide rails that include retention elements for securing the prosthetic valve, allowing for flexible adaptation to the annulus anatomy and secure attachment, and optionally a flexible skirt or baleen element for enhanced fit and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sutures are used to secure the sewing ring within the annulus, then the prosthetic valve can be implanted, but the procedure becomes very complicated requiring management of many sutures and lengthy cardiopulmonary bypass time
Solution Approach 1:
The patent extracts the complex suture management system and replaces it with a simplified rail-based guidance and attachment system. The guide rails provide predetermined pathways that eliminate the need for manual suture routing and knot tying, directly reducing procedural complexity while maintaining secure attachment through the retention element mechanism
Solution Approach 2:
The guide rails act as intermediary elements between the prosthetic valve and the annulus. These rails provide a structured mediation system that guides the prosthetic valve into proper alignment and facilitates attachment through retention elements, replacing the direct complex suture-based interaction with an intermediate guiding structure
2Adaptability or versatility
If the sewing ring is made flexible to conform to the annulus anatomy, then better anatomical fit is achieved, but the valve and sewing ring may not mate together effectively creating leaks and impairing performance
Solution Approach 1:
The guide rails are pre-configured with retention elements at specific locations before implantation. These predetermined attachment points ensure that when the prosthetic valve is guided along the rails, it engages at precise locations that maintain proper seating geometry, thus preserving valve-seating effectiveness even when the sewing ring is flexible and conforms to varying annulus shapes
Solution Approach 2:
The patent replaces the traditional mechanical suture-tensioning system with a rail-guided retention element system. This substitution provides more predictable and precise positioning of the prosthetic valve relative to the sewing ring, ensuring effective mating and sealing while allowing the sewing ring to flex and conform to the annulus anatomy
3Adaptability or versatility
If multiple component valves are used to allow separate implantation of sewing ring and valve, then flexibility in implantation is improved, but the complexity of securing them together increases
Solution Approach 1:
The prosthetic valve is designed to nest within the structure defined by the guide rails and sewing ring assembly. The guide rails are positioned within or adjacent to the sewing ring, and the prosthetic valve engages these nested structures, allowing separate implantation of components while simplifying their final assembly through the nested configuration
Solution Approach 2:
The guide rails serve as intermediary structures that bridge the sewing ring and the prosthetic valve. By providing predetermined pathways and retention elements, the rails mediate the connection between the separately implanted components, reducing the complexity of securing them together while maintaining implantation flexibility
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 2A~2D
AI summary
A heart valve assembly includes a prosthesis and a prosthetic valve to replace a preexisting natural or prosthetic heart valve within a biological annulus. The prosthesis includes an annular member, a flexible core at least partially defining a sewing cuff extending radially outwardly from the annular member, a rail ring disposed between the flexible core and the annular member, and a plurality of guide rails extending from the rail ring through respective openings in the flexible core. A fabric covering covers the prosthesis, and the guide rails extend through respective openings in the fabric covering. The prosthetic valve includes a frame including receptacles for receiving respective guide rails. After implanting the prosthesis within a biological annulus, the prosthetic valve is advanced along the guide rails until retention elements on the guide rails engage the receptacles to secure the prosthetic valve relative to the prosthesis.