Prosthetic Heart Valve Suture Loop for Low-Stress Assembly
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Solution Overview
Problem
Conventional prosthetic heart valves require laborious and time-consuming assembly processes, particularly in securing the leaflets and skirts to the frame, which creates stress points and increases the risk of wear and tear during diastole, limiting their applicability to frail patients.
Innovation Solution
A method involving a suture loop with figure-eight shaped windings is used to secure the inner skirt to the frame, eliminating direct stitching to the struts and reducing assembly time, while distributing diastolic loads more effectively through the frame.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional stitching methods are used to secure leaflets to the inner skirt, then the assembly is secure, but the process is time-consuming and laborious
Solution Approach 1:
The patent extracts the stitching operation from the assembly process by using pre-attached leaflets that come integrated with the inner skirt as a single unit. This eliminates the time-consuming step of individually stitching each leaflet to the skirt while maintaining secure attachment through the factory-prepared integration.
Solution Approach 2:
The leaflets are preliminarily attached to the inner skirt during manufacturing before delivery to the clinical setting. This preliminary action ensures proper positioning and secure attachment is achieved in advance, eliminating the need for time-consuming intra-procedural stitching operations.
2Reliability
If conventional stitching methods are used to secure skirts to the frame, then the connection is secure, but stress points are created on the leaflets during diastole
Solution Approach 1:
The patent removes the stitching operation that creates stress points on the leaflets. Instead of stitching leaflets to the skirt, the leaflets are pre-attached as an integrated unit, and the skirt is secured to the frame using alternative methods that do not involve penetrating stitches through the leaflet tissue, thereby eliminating stress concentration points.
Solution Approach 2:
The inner skirt acts as an intermediary element between the leaflets and the frame. The skirt is secured to the frame at locations that do not directly transmit stress to the leaflets, while the pre-attached leaflet-skirt assembly maintains proper positioning without requiring stitches through the leaflet material itself.
3Reliability
If conventional stitching methods are used, then secure attachment is achieved, but wear and tear increases during working cycles
Solution Approach 1:
The patent extracts the stitching process from the final assembly, using pre-attached leaflets that are integrated with the inner skirt during manufacturing. This eliminates repeated stitching operations and associated wear and tear on the leaflet material during assembly and reassembly procedures.
Solution Approach 2:
All attachment operations are performed preliminarily during manufacturing under controlled conditions. The pre-attached leaflet-skirt assembly is designed to minimize wear during subsequent handling and implantation, extending the operational life of the valve components.
Data Source
AI summary
In some aspects, a prosthetic heart valve can include an annular frame, an annular skirt secured to the annular frame, and a suture loop secured to the annular skirt. The annular frame can be radially expandable from a radially compressed configuration to a radially expanded configuration. The annular skirt can include an edge portion. The suture loop can include a plurality of first sections and a plurality of second sections. Each one of the plurality of second sections of the suture loop can be coupled to the frame with a separate suture that extends around the second section.