Annular Spacer Prosthetic Valve Anchoring
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Solution Overview
Problem
Dilation of the mitral valve annulus leads to incomplete coaptation of valve leaflets, resulting in blood regurgitation and decreased cardiac output, necessitating a prosthetic valve replacement solution that effectively anchors and seals a prosthetic valve within the native valve environment.
Innovation Solution
A prosthetic valve system featuring guide members anchored to commissures, a collapsible valve support with expandable elements, and sealing mechanisms to secure the prosthetic valve in place, ensuring proper alignment and sealing against native leaflets, utilizing expandable frames and sealing materials to prevent regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to replace a dilated native valve, then regurgitation is reduced and cardiac output is improved, but the complexity of the implantation procedure and device structure increases
Solution Approach 1:
The prosthetic valve is nested within a collapsible support structure that can be compressed for delivery and then expanded at the implantation site. The valve support includes an inner frame and an outer frame that nest together, allowing the entire assembly to be delivered through a catheter and then deployed in place, reducing the need for open-heart surgery while maintaining sealing effectiveness
Solution Approach 2:
The prosthetic valve system is divided into separate functional components: the valve itself, the collapsible support structure, anchoring mechanisms (such as hooks or barbs), and sealing elements. This segmentation allows each component to be optimized independently and simplifies the implantation process by enabling staged deployment of components
2Ease of operation
If a collapsible valve support is used to facilitate minimally invasive delivery, then the implantation procedure becomes less invasive, but the structural stability and sealing capability of the prosthetic valve are compromised
Solution Approach 1:
The valve support transitions from a collapsible state during delivery to an expanded stable state at implantation. The support structure includes flexible yet load-bearing materials that allow compression for catheter delivery but provide rigid support when expanded, ensuring both ease of implantation and long-term stability
Solution Approach 2:
Anchoring mechanisms such as hooks, barbs, or engagement features are pre-integrated into the valve support structure before delivery. These anchoring elements are positioned to engage with the native annulus or valve tissue upon expansion, ensuring immediate and secure anchoring without requiring additional surgical steps
3Reliability
If the prosthetic valve is designed to seal against native leaflets, then regurgitation is prevented, but the risk of interference with left ventricular outflow tract increases
Solution Approach 1:
The sealing mechanism is localized to specific regions of the valve support where it contacts the native annulus or leaflets, rather than requiring uniform contact around the entire circumference. This localized sealing approach prevents regurgitation while leaving the outflow tract region clear of obstructions
Solution Approach 2:
The valve support structure is designed with asymmetric features that direct sealing forces away from the outflow tract region. The support may have varying radial stiffness or engagement features distributed unevenly around the circumference, providing enhanced sealing where needed while maintaining patency of the outflow tract
Data Source
AI summary
Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular spacer configured for implantation with a native heart valve opening and a central valve section configured for disposal within the annular spacer. The central valve section may include at least one anchoring protrusion configured to anchor the central valve section against axial movement relative to the annular spacer. During deployment, the central valve section may be expanded radially within the heart into an at least partially-expanded configuration while at least a portion of the central valve section is situated outside of a space opening of the annular spacer, and moved upstream while remaining in the at least partially-expanded configuration until the anchoring protrusion engages the annular spacer.