Capsule Marker Layout for Transcatheter Valve Rotational Alignment
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Solution Overview
Problem
Existing delivery systems for transcatheter heart valve prostheses lack effective methods for monitoring and ensuring proper rotational orientation during navigation and deployment, particularly in minimally-invasive procedures, which can lead to complications such as blocking coronary ostia and requiring extensive recuperation times.
Innovation Solution
The use of delivery systems with capsules featuring radiopaque markers that indicate the desired rotational orientation of the transcatheter heart valve prosthesis, allowing clinicians to align the capsule using cusp overlap viewing angles to ensure proper alignment with native heart valve commissures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiopaque markers are added to the capsule for rotational orientation indication, then rotational alignment capability is improved, but device complexity increases
Solution Approach 1:
The patent uses radiopaque markers with different radiopacity characteristics (appearing as different shades or patterns under fluoroscopy) to indicate rotational orientation. The markers are designed to create visually distinct patterns when viewed from different angles, enabling clinicians to determine the correct rotational alignment of the capsule during the procedure.
2Measurement precision
If multiple markers are disposed on the capsule for orientation indication, then rotational orientation monitoring is improved, but manufacturing complexity increases
Solution Approach 1:
The rotational orientation indication system is segmented into multiple discrete markers positioned at specific locations on the capsule. Each marker serves a specific function in the overall orientation indication, and they can be manufactured separately and attached to the capsule during assembly, simplifying the manufacturing process compared to creating a single complex orientation indicator.
3Reliability
If traditional surgical valve replacement is performed, then complete valve replacement is achieved, but patient trauma and recuperation time increase
Solution Approach 1:
The patent replaces the traditional open surgical mechanical approach (sternotomy, cardiopulmonary bypass, direct surgical manipulation) with a minimally invasive transcatheter delivery system. The heart valve prosthesis is delivered through a catheter in the collapsed state, advanced through the vasculature to the implant location, and then expanded in situ, eliminating the need for major surgical incisions and bypass procedures.
Data Source
AI summary
A capsule of a delivery system for a transcatheter heart valve prosthesis includes markers for rotationally orienting the capsule within a native valve. The capsule includes markers that are sized and located on the capsule such that when viewed in a cusp overlap viewing angle image, the markers indicate whether the capsule is in a desired rotational orientation. Methods for rotationally aligning a capsule of a delivery system containing a transcatheter heart valve prosthesis within a native valve are also provided.