Prosthetic Valve Leaflet Attachment Without Fabric Skirts
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Solution Overview
Problem
Prosthetic heart valves often experience thrombus formation due to tissue ingrowth in fabric components, leading to reduced leaflet motility, impaired coaptation, and increased transvalvular pressure gradient.
Innovation Solution
A prosthetic valve design featuring a frame with intersecting struts, where leaflets are coupled via primary and secondary sutures in an in-and-out pattern, utilizing self-tightening constructs to minimize fabric use and reduce tissue ingrowth, with secondary sutures having a smaller diameter than primary sutures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If fabric components are used to couple leaflets to the frame, then ease of manufacture is improved, but tissue ingrowth and thrombus formation occur leading to reduced reliability
Solution Approach 1:
The patent removes fabric components from the prosthetic valve structure and replaces them with direct suture attachment of leaflets to the frame. This extraction eliminates the interface where tissue ingrowth occurs, thereby maintaining ease of manufacture while significantly improving reliability by preventing thrombus formation and preserving leaflet motility.
2Device complexity
If fabric components are incorporated as intermediaries for coupling leaflets to the frame, then device complexity is reduced, but tissue ingrowth occurs causing impaired coaptation and increased transvalvular pressure gradient
Solution Approach 1:
The fabric intermediary is completely removed from the device structure. Leaflets are directly sutured to the frame using primary and secondary sutures with self-tightening constructs, eliminating the fabric component that would otherwise serve as an intermediate coupling element. This maintains simple device architecture while eliminating the source of tissue ingrowth.
3Reliability
If self-tightening constructs are used in secondary sutures, then leaflet motility and coaptation are enhanced, but device complexity increases
Solution Approach 1:
The secondary suture incorporates self-tightening constructs that automatically adjust and tighten around the frame struts without requiring external intervention or complex mechanical components. The suture material itself provides the tightening function through its structural properties, enhancing leaflet motility and coaptation while maintaining relatively simple device architecture.
Data Source
AI summary
The present invention relates to implantable prosthetic devices, such as prosthetic heart valves, and to attachment configurations and methods of attaching soft components, such as leaflets or skirts, to frames of such prosthetic valves. A method of assembling a prosthetic valve includes threading a primary suture in an in-and-out pattern through a cusp end portion of a leaflet, approximating the cusp end portion with the primary suture threaded there-through to at least one strut of a frame of the prosthetic valve, and stitching a secondary suture through the primary suture and around the at least one strut in a manner that forms a plurality of self-tightening constructs. Each self-tightening construct is formed to include at least one loop configured to constrict under tension around the strut.