Mitral Valve Holder with Suture Tensioning Mechanism
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Solution Overview
Problem
Current holders for tissue-type prosthetic mitral valves face challenges with suture looping, which can damage tissue leaflets and interfere with the implantation procedure, especially during minimally-invasive surgeries, due to entanglement of sutures with commissure post tips.
Innovation Solution
A holder system that includes a commissure constriction mechanism with a rod and adapter design to tension attachment sutures, preventing suture looping by pulling commissure post tips inward and maintaining tension, thereby reducing the risk of entanglement and improving implantation efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the holder is attached to the inflow side of the mitral valve for standard delivery, then the valve can be delivered through the sewing ring, but the outflow commissure posts become entangled with pre-installed anchoring sutures causing suture looping
Solution Approach 1:
The holder is designed with pre-positioned attachment sutures that are tensioned before valve implantation. The sutures are attached to the holder in advance and extend through the sewing ring, so when the valve is delivered, the sutures are already in place to prevent entanglement of the commissure posts with anchoring sutures.
Solution Approach 2:
The holder acts as an intermediary device between the delivery system and the valve. It provides a stable attachment point for the sutures and maintains their tension during delivery, preventing the commissure posts from becoming entangled with the anchoring sutures in the heart tissue.
2Object-affected harmful factors
If minimally-invasive access channel is used for valve implantation, then patient trauma is reduced, but suture looping and entanglement problems are compounded
Solution Approach 1:
The attachment sutures are pre-configured on the holder before the valve is introduced through the minimally-invasive access channel. This preliminary arrangement ensures that the sutures are properly positioned and tensioned even when delivered through a small incision, preventing suture looping in the constrained space.
Solution Approach 2:
The holder design provides localized control over the attachment sutures at specific points on the valve. This localized quality control ensures that each suture is properly tensioned and positioned, preventing entanglement even when delivered through the limited space of a minimally-invasive access channel.
3Stability of the object's composition
If the commissure posts are left free during delivery, then valve flexibility is maintained, but the posts become entangled with anchoring sutures causing suture looping
Solution Approach 1:
The attachment sutures are pre-attached to the commissure posts and tensioned on the holder before delivery. This preliminary action maintains the posts in a controlled position that preserves valve flexibility while preventing entanglement with anchoring sutures during the implantation process.
Solution Approach 2:
The holder maintains continuous tension on the attachment sutures throughout the delivery process. This continuous action keeps the commissure posts in a controlled position, preventing entanglement while allowing the valve to maintain its flexibility for proper coaptation after implantation.
4Reliability
If a complex holder mechanism is used to prevent suture looping, then suture entanglement is reduced, but device complexity increases
Solution Approach 1:
The holder is segmented into simple, discrete components: attachment sutures, a holder body with attachment points, and a tensioning mechanism. This segmentation allows each component to perform its specific function of preventing suture looping while keeping the overall device structure simple and manageable.
Solution Approach 2:
The attachment sutures are designed to be self-tensioning on the holder. Once attached, the sutures automatically maintain tension on the commissure posts without requiring complex active control mechanisms, thereby preventing suture looping with a simple passive structure.
Data Source
AI summary
An improved holder and storage system for a tissue-type prosthetic mitral heart valve that constricts the commissure posts of the valve and prevents suture looping. A rod axially movable relative to the holder tensions lengths of attachment sutures that extend between the commissure post tips to create a tent and flex the tips inward, thus helping to prevent looping of any of an array of pre-implanted sutures around the leading tips during delivery of the valve. The holder has a safety mechanism that prevents valve delivery before the rod is deployed. One embodiment automatically deploys the rod upon opening a storage jar. One embodiment permits a delivery handle to directly deploy the rod, while another uses a separate worm screw and coupling. A holder clip that attaches to a packaging sleeve may be formed of flexible members meshed together from which the heart valve and holder are easily pulled free to eliminate a step of decoupling the clip from the sleeve.