Braided Mitral Valve Anchor Using Nested Discs
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Solution Overview
Problem
Current methods for mitral valve replacement require large intercostal punctures, leading to increased trauma and morbidity due to the complexity and size of the anchoring devices needed, which is not as well-tolerated in elderly patients and does not eliminate the need for extra-corporeal circulation in valve replacement surgeries.
Innovation Solution
A flexible anchor system for a prosthetic heart valve comprising a first and second disc biased towards a convex shape, connected by a neck, and secured with a cuff, which can be deployed through a smaller delivery tube without the need for an intercostal puncture, using a collapsible tether and shape-memory materials to secure the valve in place within the native valve annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large anchor is used to secure the prosthetic valve against the heart, then adequate security is achieved, but the intercostal puncture diameter must be increased
Solution Approach 1:
The anchor is designed with a nested structure where the first and second discs can be positioned inside each other during delivery, allowing the large anchor to pass through a small puncture. Once deployed, the discs expand to provide adequate security against the heart.
Solution Approach 2:
The anchor transitions from a compressed delivery state to an expanded deployed state. The discs are biased toward dome shapes and can be dynamically positioned to engage the heart surface, providing security only when needed in the deployed configuration.
2Reliability
If a large intercostal puncture is made to accommodate the anchor, then the valve can be secured, but patient trauma increases
Solution Approach 1:
The anchor components are nested within each other during delivery through a small puncture, minimizing trauma. After deployment, the nested structure expands to provide the necessary anchoring security.
Solution Approach 2:
The anchor is constructed from flexible wire mesh that can be compressed for delivery through small punctures and then expands to provide secure anchoring, reducing patient trauma while maintaining reliability.
3Reliability
If traditional open heart surgery is performed, then complete valve replacement is achieved, but morbidity and cost increase due to extra-corporeal circulation
Solution Approach 1:
The procedure extracts the need for open heart surgery and extra-corporeal circulation by delivering the prosthetic valve through a catheter-based approach. The anchor secures the valve without requiring full surgical exposure, eliminating the harmful effects of traditional open surgery.
Solution Approach 2:
The anchor acts as an intermediary device that secures the prosthetic valve to the heart tissue without requiring open surgical access. This mediator enables minimally invasive delivery while maintaining complete valve replacement functionality.
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 reduces the diameter of the puncture required for anchoring, minimizing trauma and potentially eliminating the need for intercostal punctures, thereby improving patient outcomes and reducing morbidity and costs associated with valve replacement therapies by avoiding extra-corporeal circulation.
Implementation Method 1
The anchor may be constructed from a shape-memory material and may be compressed into a delivery tube and then expanded
Implementation Method 2
An elastically deformable frame may support the first disc. The frame may be invertible and biased toward a cone shape.
Data Source
Figure 1
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Figure 3~4
AI summary
A prosthetic heart valve (110) may include a valve portion (136), a tether (226) connected to the valve portion, and an anchor (210) for connecting the tether to the wall of the heart. The anchor may include a flexible first disc (214) biased toward a first shape that is convex in a first direction and a neck (228) extending from the first disc in a second direction opposite the first direction. The neck has a first end connected to the first disc and a second end. The anchor may further include a flexible second disc (218) connected to the second end of the neck and biased toward a second shape that is convex in the first direction. When deployed, the first and second discs sandwich the wall of the heart.