Transcatheter Valve Rotation for Predictable Commissural Alignment
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Solution Overview
Problem
The challenge in transcatheter valve replacement procedures is the unpredictable alignment of commissural posts of the replacement valve with the existing valve's commissures, which complicates the deployment process and can vary based on practitioner skill and duration, especially in valve-in-valve replacements.
Innovation Solution
A transcatheter delivery system with a balloon shaft and actuator mechanism that allows precise rotation and locking of the valve prosthesis, using a 1:1 or 10:8 ratio of actuator to valve rotation, and includes alignment markers for accurate commissural alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a catheter is used to deliver the valve prosthesis through the patient's vasculature, then the procedure becomes minimally invasive, but the ability to align commissures predictably deteriorates
Solution Approach 1:
The delivery system pre-establishes a rotational locking mechanism and actuator system before deployment, allowing the practitioner to rotate and lock the valve prosthesis at the target site. This preliminary preparation of the alignment mechanism enables precise commissural alignment despite the minimally invasive delivery approach through the vasculature.
Solution Approach 2:
The patent introduces an intermediary rotational locking mechanism and actuator system between the catheter and the valve prosthesis. This intermediary mechanism translates the practitioner's manual rotation into controlled valve rotation and locking, serving as a mediator that enables precise alignment while maintaining the minimally invasive delivery route.
2Ease of operation
If the practitioner relies on imaging for positioning, then the procedure remains minimally invasive, but the alignment capability varies broadly based on skillset and duration
Solution Approach 1:
The delivery system incorporates a self-contained rotational locking mechanism that allows the valve prosthesis to be rotated and locked independently of continuous practitioner intervention. Once the actuator is engaged, the system maintains the aligned position automatically, making the alignment process self-sustaining and less dependent on practitioner skill level or procedure duration.
Solution Approach 2:
The system provides tactile feedback through the rotational locking mechanism, allowing the practitioner to sense when the valve prosthesis has been rotated to the correct orientation and locked in place. This feedback mechanism enhances alignment reliability by providing real-time confirmation of proper positioning, reducing dependence on imaging interpretation.
3Adaptability or versatility
If a second replacement valve is inserted into an existing damaged valve, then valve-in-valve replacement is achieved, but the difficulty of aligning commissures increases
Solution Approach 1:
The delivery system employs a dynamic rotational locking mechanism that can be engaged and disengaged as needed. During valve-in-valve replacement, the practitioner can rotate the second valve prosthesis using the actuator and then lock it in the aligned position. The dynamic nature of the locking mechanism allows for easy engagement during alignment and stable holding during deployment, managing the complexity of valve-in-valve alignment.
Solution Approach 2:
The rotational alignment function is segmented from the deployment function. The actuator handles only rotation and locking, while the balloon handles only deployment. This segmentation of functions simplifies the overall process of valve-in-valve replacement by allowing the practitioner to focus on alignment through the actuator without simultaneously managing deployment operations.
Data Source
AI summary
A replacement heart valve prosthesis is loaded onto a balloon mounted onto a balloon shaft of a catheter system. The balloon shaft is rotatably engaged with an actuator on the handle of the catheter system. Rotation of the actuator by a first amount in a first direction permits rotation of the heart valve prosthesis by a known amount during the procedure so that alignment of the commissures of the replacement valve with the commissures of the existing valve can be predictably achieved.