Prosthetic Heart Valve Reverse-Running Suture Pattern
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Solution Overview
Problem
Existing prosthetic heart valves for transcatheter aortic and mitral valve replacement face challenges in minimizing paravalvular leakage and ensuring optimal seating within the native valve annulus, which can affect the durability and long-term performance of the valves.
Innovation Solution
The development of a prosthetic heart valve with a collapsible and expandable stent featuring commissure attachment features, a valve assembly with a cuff and multiple leaflets, and a pre-assembled suture pattern using reverse-running stitches to secure the leaflets to the stent and cuff, thereby enhancing attachment stability and reducing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suture patterns are used to attach leaflets to the stent and cuff, then the attachment process is simpler, but the attachment stability is insufficient and paravalvular leakage occurs
Solution Approach 1:
The suture pattern is divided into multiple discrete reverse-running stitches distributed across the leaflet attachment region. Each stitch acts as an independent attachment point, collectively providing enhanced stability while maintaining manageable complexity through modular repetition of the basic stitch unit.
Solution Approach 2:
The reverse-running stitches are pre-assembled onto the leaflets before final implantation. This preliminary attachment configuration ensures proper positioning and tension distribution is established in advance, improving attachment stability while reducing the complexity of intraoperative suturing procedures.
2Duration of action of stationary object
If uniform stress distribution across the suture pattern is achieved, then long-term durability is improved, but the suture design becomes more complex
Solution Approach 1:
The reverse-running stitches are strategically positioned at specific locations across the leaflet attachment region rather than being uniformly distributed. This localized placement optimizes stress distribution at critical high-load areas while maintaining overall durability, balancing enhanced performance with controlled design complexity.
3Object-affected harmful factors
If the valve assembly is securely attached to minimize leakage, then sealing performance improves, but the attachment procedure becomes more time-consuming
Solution Approach 1:
The reverse-running stitches are pre-configured and pre-positioned on the leaflets during manufacturing, ensuring proper alignment and tension before implantation. This preliminary preparation eliminates time-consuming intraoperative alignment and adjustment procedures while achieving secure attachment that minimizes paravalvular leakage.
Solution Approach 2:
The attachment system uses multiple discrete reverse-running stitches rather than a single complex continuous suture. This segmentation allows for simpler, faster individual stitch placement while collectively achieving superior sealing performance, reducing overall procedure time.
Data Source
AI summary
In some embodiments, a prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, a valve assembly coupled to the collapsible and expandable stent, the valve assembly comprising a cuff and a plurality of leaflets, and a suture pattern coupling at least one of the plurality of leaflets to at least one of the cuff and the collapsible and expandable stent, the suture pattern comprising a reverse-running stitch having a first leg and a second leg.