Commissure-Attached Aortic Valve Holder
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Solution Overview
Problem
Conventional aortic valve holders are bulky and obstructive, making it difficult for surgeons to perform suturing and tie-off operations due to their size and design, which can lead to increased risk of puncture or improper suturing, especially in patients with a small aortic root.
Innovation Solution
A slim, ergonomic aortic valve holder that attaches directly to the commissure tips of the valve, reducing bulk and obstructions, with a central hub and radially projecting legs that minimize visibility obstruction and enhance tactile feedback, featuring a direct and exclusive attachment to the commissure tips without moving parts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional bulky aortic valve holders are used, then the valve can be securely held during implantation, but the holder obstructs the surgeon's access to the valve base and makes suturing difficult
Solution Approach 1:
The holder is segmented into multiple thin legs that attach to different commissure tips, distributing the holding function across multiple points rather than using a single bulky structure. This segmentation allows the legs to be slender and less obstructive while maintaining secure valve attachment.
Solution Approach 2:
The holder employs thin, flexible legs instead of bulky rigid structures. These thin legs can bend and conform to the valve structure, providing secure attachment while minimizing obstruction to the surgeon's access and visibility during suturing operations.
2Reliability
If conventional bulky holders are used, then the valve is protected during implantation, but the risk of puncture or improper suturing increases
Solution Approach 1:
The thin, flexible legs provide valve protection through conformal attachment and gentle contact, avoiding the sharp edges and rigid structures of bulky holders that could cause punctures. The flexibility allows the legs to adapt to the valve surface without creating stress concentration points.
Solution Approach 2:
The holder is designed as a disposable device with simple, thin construction that eliminates complex mechanical components. This simplicity reduces the risk of improper suturing by providing a straightforward attachment geometry that is easier to work with during the implantation procedure.
3Ease of operation
If the holder attaches to commissure tips exclusively, then tactile feedback is improved, but the attachment structure must be precisely positioned
Solution Approach 1:
The attachment structure incorporates features such as compliance elements and adjustable geometry that allow for parameter variations in the attachment process. This enables tolerant positioning while maintaining secure attachment to the commissure tips, reducing the impact of manufacturing precision limitations.
Solution Approach 2:
The holder employs different structural characteristics at different locations: the legs have specific attachment geometries optimized for commissure tip engagement, while other portions have different properties for flexibility and tactile feedback. This local differentiation allows precise attachment at critical points while maintaining overall operational ease.
Data Source
AI summary
A holder for a flexible leaflet prosthetic aortic heart valve that is less bulky than earlier holders and minimizes obstructions to vision and working space around the valve to facilitate implantation thereof. The holder may have a central hub and three outwardly extending legs that connect directly and exclusively to tips of the commissures of the aortic heart valve for better tactile feedback when parachuting and seating the valve in the annulus. The legs are sized so that they do not overlap the commissure tips and therefore afford a better view of the sewing ring adjacent the commissures. The legs may be narrow in the midsection or split into two rails to increase visibility of the valve leaflets. The hub may be vaulted axially upward relative to the outer ends of the legs to further increase visibility of the valve. A more secure engagement between the central hub and a delivery handle is also provided to ensure the holder/handle connection does not become loose during suture placement through the sewing ring and fewer handle revolutions are required to screw in and unscrew the handle from the holder.