Heart Valve Leaflet Attachment Using Single-Sheet Tissue
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Solution Overview
Problem
The process of attaching tissue leaflets to a stent in transcatheter valve replacement devices is labor-intensive and time-consuming due to the need for hundreds of sutures, increasing manufacturing costs and time.
Innovation Solution
A heart valve replacement device featuring a stent with a single sheet of tissue forming at least three leaflets, attached to the stent with fewer than forty sutures, utilizing a mold and cross-linking process to secure the valve to the stent.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional hand-sewn attachment method is used, then secure attachment of leaflets to stent is achieved, but manufacturing time and labor cost increase significantly
Solution Approach 1:
Attachment features are pre-formed on the stent structure before leaflet attachment, and tissue portions are pre-positioned on the stent. This preliminary preparation allows for rapid final attachment using minimal sutures, resolving the contradiction between secure attachment and manufacturing time by doing preparatory work in advance
Solution Approach 2:
The stent is divided into multiple attachment features distributed around its structure, each capable of independently securing tissue. This segmentation allows the attachment process to be distributed across multiple locations rather than requiring continuous hand-sewing, reducing overall manufacturing time while maintaining secure attachment at each segment
2Reliability
If traditional hand-sewn attachment method is used, then secure attachment of leaflets to stent is achieved, but manufacturing cost increases due to labor intensity
Solution Approach 1:
Attachment features are pre-formed on the stent and tissue portions are pre-positioned during stent fabrication, transforming complex manual attachment work into a simpler final assembly step. This reduces the need for skilled labor and decreases manufacturing cost while maintaining attachment security
Solution Approach 2:
The traditional mechanical hand-sewing process is replaced with a system using pre-formed attachment features that require minimal suturing. This substitution of the attachment mechanism reduces labor intensity and manufacturing cost while maintaining reliable attachment
3Loss of time
If fewer sutures are used, then manufacturing time and cost are reduced, but attachment security may be compromised
Solution Approach 1:
Attachment features are pre-formed on the stent and tissue portions are pre-positioned, creating a prepared system where minimal sutures are all that is needed to secure the attachment. This preliminary preparation ensures that even with fewer sutures, attachment security is maintained because the geometry and positioning are already optimized
Solution Approach 2:
Attachment features are strategically positioned at specific locations on the stent where they provide maximum structural support and attachment security. This local optimization ensures that sutures placed at these critical locations provide enhanced attachment strength, allowing reduced overall suture count while maintaining security
Data Source
AI summary
A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.