Rotational Identifier for Heart Valve Alignment
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Solution Overview
Problem
The challenge in minimally invasive aortic valve replacement procedures lies in accurately positioning prosthetic heart valves due to the lack of line-of-sight visualization, leading to difficulties in interpreting two-dimensional radiographic images and potential improper placement or device migration.
Innovation Solution
The use of heart valve prostheses with three commissural posts, where the posts are shaped to have radiographic identifiers, and a valve retainer with a rotational identifier to facilitate correct rotational alignment with native commissures, utilizing radiographic imaging to ensure precise positioning during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiographic imaging is used for positioning the prosthesis, then positioning information is obtained, but the visualization is limited to two dimensions making accurate orientation difficult
Solution Approach 1:
The patent introduces a rotational identifier (such as a radiopaque marker or visual indicator) on the delivery tool that provides rotational orientation information. This additional dimensional information allows the physician to determine the three-dimensional orientation of the prosthesis from two-dimensional radiographic images, effectively adding a rotational dimension to the positioning data.
Solution Approach 2:
The rotational identifier acts as an intermediary between the delivery tool and the radiographic imaging system. It translates the three-dimensional rotational state of the delivery tool into a two-dimensional visual signal that can be interpreted from radiographic images, enabling accurate orientation determination without direct line-of-sight visualization.
2Measurement precision
If the physician rotates the delivery tool to achieve proper alignment, then positioning accuracy improves, but the time required for implantation increases
Solution Approach 1:
The rotational identifier provides real-time feedback to the physician about the rotational orientation of the delivery tool during the implantation procedure. By monitoring the position of the rotational identifier in radiographic images, the physician can make precise rotational adjustments and confirm proper alignment quickly, reducing the time needed to achieve accurate positioning.
Solution Approach 2:
The rotational identifier is pre-positioned on the delivery tool at known locations relative to the prosthesis. This preliminary configuration allows the physician to predict the orientation of the prosthesis based on the identifier's position, enabling faster alignment decisions and reducing the trial-and-error rotation process.
3Ease of operation
If visual markers are added to the delivery tool, then rotational alignment is facilitated, but the device complexity increases
Solution Approach 1:
The rotational identifier may utilize radiopaque materials that appear distinct (analogous to color changes in visual terms) on radiographic images. This allows the identifier to be easily distinguished from other structures in the imaging field, providing clear rotational orientation information without requiring complex multi-component marker systems.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach simplifies the implantation process by reducing the time and steps required, enhancing the accuracy of valve placement and reducing the risk of improper positioning or device migration, thereby improving the success rate of minimally invasive procedures.
Implementation Method 1
the commissural posts are shaped so as to define radiographic identifiers
Data Source
Figure 1~2B
Figure 3
Figure 4
AI summary
A valve retainer is connected to an elongate delivery member. The valve retainer is configured to releasably secure a prosthesis (e.g., a heart valve prosthesis) to the delivery member during delivery to a target site in a body (e.g., a native valve annulus). The valve retainer includes a rotational identifier that identifies the rotational orientation of the valve retainer when the valve retainer is positioned proximate to the target site. A heart valve prosthesis can include a commissural post that has a predetermined rotational position relative to the rotational identifier, such that the heart valve prosthesis can be rotationally aligned with the native commissures of the native valve by rotating the delivery member and the valve retainer until the commissural post is aligned with a native valve commissure and the rotational identifier is visible.