Prosthetic Heart Valve Constrained Inner Frame
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Solution Overview
Problem
Existing prosthetic heart valves face challenges in achieving controlled and predictable expression during deployment, which can lead to damage of the valve leaflets and native anatomy.
Innovation Solution
A prosthetic heart valve design featuring a collapsible and expandable outer frame, an inner frame with a constraining band, and a prosthetic valve assembly, which allows for controlled deployment by limiting the expansion of the inner frame to prevent over-stretching of the valve leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the prosthetic heart valve is deployed to expand into the native valve annulus, then the valve replaces the native valve and provides heart valve function, but the deployment process may cause damage to the valve leaflets and native anatomy due to uncontrolled expansion
Solution Approach 1:
The constraining band is pre-positioned on the inner frame at a specific location before deployment. This preliminary placement ensures that when the valve is deployed, the expansion is automatically limited to a controlled extent, preventing over-expansion damage to the valve leaflets and native anatomy while still allowing sufficient expansion for proper valve function.
Solution Approach 2:
The constraining band acts as an intermediary element between the inner frame and the valve leaflets. It mediates the expansion process by providing a physical barrier that limits the maximum expansion distance, thereby controlling the deployment force and preventing direct damage to the delicate valve leaflets and surrounding native tissue.
2Ease of operation
If the inner frame is allowed to expand freely during deployment, then the prosthetic valve assembly can be fully expressed, but the valve leaflets may become over-stretched and damaged
Solution Approach 1:
The constraining band is pre-positioned on the inner frame at a specific location before deployment. This preliminary placement ensures that when the valve is deployed, the expansion is automatically limited to a controlled extent, preventing over-expansion damage to the valve leaflets and native anatomy.
Solution Approach 2:
The constraining band is positioned at a specific location on the inner frame rather than uniformly constraining the entire structure. This localized constraint allows different portions of the valve to expand to appropriate degrees, enabling full valve expression while protecting the valve leaflets from over-stretching at critical locations.
3Strength
If the constraining band is positioned closer to the inflow end of the inner frame, then the valve leaflets are better protected from over-stretching, but the prosthetic valve assembly may not fully express during deployment
Solution Approach 1:
The constraining band is positioned at an optimized specific location on the inner frame rather than uniformly constraining the entire structure. This localized constraint allows different portions of the valve to expand to appropriate degrees, enabling full valve expression while protecting the valve leaflets from over-stretching at critical locations.
Solution Approach 2:
The position of the constraining band on the inner frame is carefully selected to optimize the balance between leaflet protection and complete valve expression. By adjusting this positional parameter, the design achieves the optimal compromise where the valve leaflets are protected from over-stretching while the prosthetic valve assembly can still fully express during deployment.
Data Source
AI summary
A prosthetic heart valve includes a collapsible and expandable outer frame, a collapsible and expandable inner frame, and a prosthetic valve assembly. The outer frame may be configured to engage tissue of a native heart valve, and may have (i) an atrial portion adapted to be positioned on an atrial side of the native heart valve; (ii) a ventricle portion adapted to be positioned on a ventricle side of the native heart valve; and (iii) a narrowed waist portion between the atrial portion and the ventricle portion. The inner frame may be positioned radially inward of the outer frame and may be coupled to the outer frame. A constraining band may extend around a circumference of the inner frame. The prosthetic valve assembly may be coupled to, and positioned radially inward of, the inner frame.