Collapsible Mitral Valve Holder With Anti-Suture Looping
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Solution Overview
Problem
Existing prosthetic heart valve holders face issues with suture looping and damage during implantation, particularly in minimally invasive procedures, due to high profile designs and user error, leading to complications and the need for additional surgeries.
Innovation Solution
A new valve holder system with integrated mistake-proofing features, including a ratchet mechanism and activator dial, that ensures the anti-suture looping mechanism is engaged, allowing for collapsible designs suitable for minimal incisions, and prevents user errors by ensuring proper deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a traditional high-profile valve holder design is used, then the valve can be securely held during implantation, but the profile is too large to fit through minimal incisions
Solution Approach 1:
The valve holder employs a dynamic collapse mechanism where the commissure posts can be positioned in different configurations. During delivery, the holder collapses to a low-profile state to fit through minimal incisions. Upon deployment, the commissure posts are urged to a radial configuration to securely hold the valve at the implantation site, resolving the contradiction between compact delivery profile and secure holding capability.
2Reliability
If the valve holder is deployed too early, then the anti-suture looping mechanism is engaged, but the valve cannot be properly positioned due to user error
Solution Approach 1:
The valve holder incorporates a pre-configured anti-suture looping mechanism with a suture redirecting element positioned to engage commissure posts. The mechanism is designed to be activated at the optimal moment during implantation, preventing suture looping before it occurs while maintaining ease of operation through intuitive deployment controls.
Solution Approach 2:
A suture redirecting element acts as an intermediary component between the suture and the commissure posts. This element redirects the suture path to prevent looping around the posts, providing reliable protection while simplifying the operator's task by eliminating the need for precise manual suture management.
3Length of moving object
If the commissure posts are not pulled radially inward, then the valve profile remains large, but suture looping occurs during implantation
Solution Approach 1:
A suture redirecting element serves as an intermediary that redirects the suture path away from the commissure posts, preventing looping while allowing the valve to maintain a collapsed low-profile configuration during delivery and implantation.
Data Source
AI summary
Valve holders and introducers for delivering a prosthetic heart valve to an implant site are in various embodiments configured to facilitate insertion of prosthetic valves through small incisions or access sites on a patient's body. The valve holders can also be configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. A valve holder according to embodiments of the invention includes features that reduce or eliminate mistakes during implantation of the prosthetic valves, such as a removable activator dial and a removable handle that prevent implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate passing of a prosthetic valve between adjacent ribs of a patient. Valve holders and introducers according to the various embodiments can be used in minimally invasive procedures, such as thoracotomy procedures.