Implantable Valve Polymeric Leaflet Attachment via Frame Apertures
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Solution Overview
Problem
Current methods for attaching polymeric valve components, such as leaflets and skirts, to the frame of implantable heart valves often require sutures and can be inefficient, particularly in minimizing blood flow leakage and ensuring secure attachment under varying stress conditions.
Innovation Solution
The use of connection apertures in the frame struts that allow for secure coupling of polymeric components through thermoplastic over molding or form fitting configurations, eliminating the need for sutures and enhancing attachment security by varying aperture density and configuration based on stress concentrations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sutures are used to attach valve leaflets to the frame, then the attachment can be achieved with simple equipment, but the attachment security and reliability under stress conditions deteriorates
Solution Approach 1:
The patent replaces the mechanical suture system with a form-fit attachment mechanism where polymeric components are molded directly onto the frame struts. This eliminates sutures and provides more reliable attachment through geometric interlocking and material bonding, resolving the contradiction between attachment security and device complexity.
Solution Approach 2:
The patent merges the attachment function with the manufacturing process by using overmolding to integrate polymeric components directly onto the frame struts. This combines the leaflet attachment and frame assembly into a single integrated structure, improving reliability while maintaining simplicity.
2Reliability
If connection apertures are used to attach polymeric components, then the attachment security improves, but the manufacturing complexity increases
Solution Approach 1:
The patent incorporates connection apertures and attachment features directly into the frame strut design during manufacturing. By pre-forming these attachment structures, the patent simplifies the overall manufacturing process while ensuring secure attachment, resolving the contradiction between attachment security and manufacturing ease.
3Strength
If uniform aperture density is used throughout the frame, then the manufacturing process is simplified, but the ability to withstand stress concentrations deteriorates
Solution Approach 1:
The patent implements variable aperture density in the frame struts, with higher density in regions experiencing greater stress concentrations and lower density in less stressed areas. This localized optimization provides superior stress resistance while managing complexity through systematic distribution patterns.
4Reliability
If multiple connection apertures are used per strut, then the attachment reliability improves, but the device complexity increases
Solution Approach 1:
The patent divides each frame strut into multiple segments with individual connection apertures along its length. This segmentation allows the polymeric components to be attached at multiple discrete points, improving attachment reliability while maintaining frame structure simplicity through modular aperture placement.
Data Source
AI summary
Embodiments include implantable valves with attached polymeric components. In an embodiment, an implantable valve is included having a frame comprising a plurality of frame struts. The frame defines a central lumen and at least one of the frame struts defines a connection aperture. The implantable valve can include at least one valve leaflet including a coaptation edge and two connection portions, with one connection portion disposed on either end of the coaptation edge. The connection portion can be disposed within the connection aperture thereby coupling the valve leaflet to the frame. Other embodiments are also included herein.