Radiopaque Elements on Prosthetic Heart Valve Cuffs
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Solution Overview
Problem
Surgeons face challenges in accurately placing and positioning prosthetic heart valves during implantation procedures due to suboptimal visibility and fit, leading to potential paravalvular leakage and inefficiencies.
Innovation Solution
Incorporation of radiopaque elements on the cuff of the prosthetic heart valve, which are strategically positioned to enhance visibility under medical imaging, allowing for better alignment and positioning of the valve within the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiopaque elements are added to the prosthetic heart valve, then visibility and positioning accuracy are improved, but device complexity increases
Solution Approach 1:
The patent applies radiopaque elements to the cuff of the prosthetic heart valve to enhance visibility under fluoroscopic imaging. These elements appear as radiopaque markers that contrast with the surrounding tissue and imaging background, allowing surgeons to accurately track the position and orientation of the valve during implantation without significantly complicating the overall device structure.
2Manufacturing precision
If radiopaque elements are positioned on the cuff, then alignment precision is improved, but manufacturing complexity increases
Solution Approach 1:
The radiopaque elements are pre-positioned on the cuff during the manufacturing process, allowing precise alignment features to be established before implantation. This preliminary positioning ensures that the alignment marks are already in the correct locations relative to the valve structure, eliminating the need for complex intraoperative alignment procedures.
3Ease of operation
If the valve is made collapsible for minimally invasive delivery, then ease of operation is improved, but visibility during deployment is worsened
Solution Approach 1:
The radiopaque elements on the cuff provide visible markers that remain detectable even when the valve is in a collapsed state during delivery and deployment. This allows the surgical team to track the valve's position and orientation throughout the minimally invasive procedure, maintaining visibility despite the collapsed configuration.
Data Source
AI summary
A prosthetic heart valve for replacing a native valve includes a stent, a valve assembly, and a radiopaque element. The stent has a plurality of commissure attachment features. The valve assembly includes a plurality of leaflets and first and second cuffs. The first cuff has a proximal edge relatively close to the inflow end of the stent. The second cuff may be annularly disposed about the stent radially outward of the first cuff and radially outward of the stent. The proximal edge of the first cuff is coupled to the proximal edge of the second cuff substantially continuously along a circumference of the inflow end of the stent so that a pocket is formed between the first cuff and the second cuff. The radiopaque element is disposed within the pocket and aligned in a longitudinal direction of the stent with at least one of the plurality of commissure attachment features.