Prosthetic Mitral Valve Holders With Ratchet Retraction
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Solution Overview
Problem
Existing prosthetic heart valve holders are prone to suture looping during implantation, particularly in minimally invasive procedures, due to the high profile and complexity of existing designs, leading to user errors and potential damage to the valves.
Innovation Solution
A new valve holder system with a ratchet mechanism that pulls commissure posts radially inward, incorporating a removable activator dial to ensure proper deployment, preventing suture looping and allowing implantation through minimal incisions, and featuring integrated alignment and safety mechanisms to prevent misuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing prosthetic heart valve holders are used, then valve implantation can be performed, but suture looping occurs and user errors lead to valve damage
Solution Approach 1:
The patent applies preliminary anti-action by pre-positioning the commissure posts in a retracted configuration before implantation. The holder mechanism is designed to automatically maintain the posts in a safe position that prevents suture looping, and only after proper valve deployment does the mechanism allow the posts to assume their functional position. This preliminary protective action eliminates the harmful effect of suture looping before it can occur.
Solution Approach 2:
The patent introduces an intermediary mechanism - the specialized holder with ratchet system - that mediates between the surgeon's actions and the valve implantation process. This intermediary device controls the commissure posts' movement, ensuring they remain in a protective retracted position during critical suture placement, thereby preventing direct harmful interaction between sutures and the posts.
2Length of moving object
If a low profile valve holder is used to enable minimal incision implantation, then implantation through small incisions is enabled, but the mechanism for pulling commissure posts inward becomes more complex
Solution Approach 1:
The patent applies the nested doll principle by integrating the ratchet mechanism and commissure post retention system within the compact holder body. The ratchet components, including the pawl and toothed rack, are nested within the holder structure, allowing the complex mechanism to fit within a low-profile form factor that can pass through minimal incisions while maintaining full functionality.
Solution Approach 2:
The patent segments the holder into functional modules: a delivery shaft portion, a holder body portion, and an integrally formed connection between them. The ratchet mechanism is segmented into discrete components (pawl, rack, engagement features) that can be manufactured separately and assembled, reducing overall complexity while enabling the low-profile design necessary for minimal incision implantation.
3Reliability
If mistake-proofing features are integrated into the valve holder system, then user errors are prevented, but the device complexity increases
Solution Approach 1:
The patent applies preliminary action through the ratchet mechanism that pre-conditions the commissure posts to remain in a secure retracted position before valve deployment. The mechanism is designed so that proper deployment actions automatically trigger the release of the posts from their protected position, eliminating the need for separate manual steps and preventing user errors related to improper sequencing.
Solution Approach 2:
The patent implements self-service through the self-locking ratchet mechanism that automatically maintains the commissure posts in the correct position without requiring continuous surgeon intervention. The system serves itself by using the natural deployment forces to trigger the mechanism's transitions, and the ratchet automatically engages and disengages at the appropriate times, reducing reliance on surgeon memory and technique.
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.


