Prosthetic Valve Markings for Implant Alignment
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Solution Overview
Problem
Sutureless prosthetic heart valves lack tactile feedback for proper depth and orientation during implantation, making it challenging to ensure accurate placement and alignment with anatomical structures.
Innovation Solution
The use of visible markings on the prosthetic heart valve frame and skirt, such as circumferential and commissural alignment markings, to facilitate accurate alignment with the native valve annulus and commissures, allowing for visible feedback during implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If sutureless prosthetic heart valves are used for minimally invasive implantation, then the invasiveness of the procedure is reduced and recovery time is shortened, but tactile feedback for proper depth and orientation during implantation is lost, making accurate placement difficult
Solution Approach 1:
The patent applies visual markings (color changes) on the prosthetic valve components including the frame, skirt, and delivery system. These markings change visibility or appearance during implantation to provide real-time feedback to the operator about the position and orientation of the valve, enabling precise alignment with the annulus and commissures without tactile feedback.
Solution Approach 2:
The patent implements a visual feedback system through multiple markings that provide continuous information to the operator during the implantation process. The markings indicate when the valve is properly positioned, when expansion should occur, and when alignment is correct, creating a closed-loop feedback system that replaces the tactile feedback normally provided by sutures.
2Measurement precision
If visual markings are added to the prosthetic valve components, then alignment precision and orientation accuracy are improved, but the device complexity and manufacturing cost increase
Solution Approach 1:
The patent divides the visual feedback system into multiple independent marking elements distributed across different components (frame, skirt, delivery system). Each marking serves a specific function at a specific stage of implantation, allowing the complex alignment task to be broken down into manageable visual cues that reduce overall system complexity.
Solution Approach 2:
The markings serve multiple functions: they guide initial positioning, indicate expansion timing, confirm final alignment, and provide orientation references. This multi-functionality reduces the need for separate systems for each task, thereby reducing overall device complexity while maintaining high precision.
Data Source
Figure 1A~1B
Figure 2A~2C
Figure 3
AI summary
A device, such as a prosthetic heart valve (60), for implantation in a patient's valve, having one or more visible markings (61) configured to be aligned with one or more anatomical structures of the patient's valve, such as an annulus or a commissure. The markings facilitating accurate implantation of the device at a proper depth or in a proper orientation.