Transcatheter Heart Valve Micro-Anchor Annulus Reduction
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Solution Overview
Problem
Current methods for treating aortic insufficiency, such as open heart surgery and catheterization, are invasive and challenging due to the difficulty in anchoring prosthetic valves in a soft and dilated aortic annulus, leading to potential dislodgement and increased risk for patients, especially those who are frail or sick.
Innovation Solution
A transcatheter heart valve system with a shape-memory support structure and grabbing mechanisms, such as micro-anchors, that can be radially compressible and self-adjustable, allowing for secure engagement with native tissue without applying continuous outward force, enabling minimally invasive procedures and reducing the need for large-diameter prosthetic valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is expanded to engage and anchor within a soft and dilated aortic annulus, then anchoring stability is improved, but the continuous outward force causes further expansion of the aortic annulus leading to dislodgement
Solution Approach 1:
The support structure is designed to dynamically adjust its radial force in a periodic manner: expanding during deployment to engage the annulus, then contracting to a smaller profile after anchoring. This periodic expansion and contraction allows initial anchoring stability while avoiding continuous outward force that would cause harmful annulus expansion and dislodgement.
Solution Approach 2:
The support structure transitions from a static expanded state to a dynamic system that can change its radial dimensions. The structure is capable of expanding to engage the annulus for anchoring, then contracting to a smaller profile, adapting its state based on the anchoring phase versus the stable implanted phase, thereby eliminating continuous harmful outward force.
2Reliability
If a larger diameter prosthetic valve is used to prevent dislodgement, then anchoring stability is improved, but the delivery complexity and risk increase significantly
Solution Approach 1:
The support structure dynamically changes its diameter: expanding to a larger diameter during deployment to ensure anchoring stability, then contracting to a smaller profile after anchoring is achieved. This dynamic size adjustment allows the valve to achieve the stability of a large valve while maintaining the delivery advantages of a smaller valve, significantly reducing delivery complexity and risk.
Solution Approach 2:
The support structure undergoes periodic dimensional changes: first expanding to a larger diameter for anchoring engagement, then contracting to a smaller diameter for stable implantation. This periodic size variation allows the system to achieve anchoring stability equivalent to a large valve while maintaining the low delivery complexity of a smaller valve.
3Reliability
If open heart surgical valve replacement is performed, then valve replacement effectiveness is improved, but patient trauma and invasiveness increase
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a catheter-based delivery system. The support structure is delivered through a catheter and deployed within the native valve, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart. This substitution maintains valve replacement effectiveness while dramatically reducing patient trauma and invasiveness.
4Reliability
If a prosthetic valve exerts continuous outward force to maintain anchoring, then anchoring stability is improved, but the aortic annulus becomes further expanded and dislodgement risk increases
Solution Approach 1:
The support structure applies radial force periodically rather than continuously: expanding to exert outward force during deployment to achieve anchoring engagement, then contracting to minimize or eliminate continuous outward force. This periodic force application maintains anchoring stability while preventing further harmful expansion of the aortic annulus diameter.
Solution Approach 2:
The support structure transitions from a static expanded configuration that exerts continuous outward force to a dynamic configuration that can contract. By dynamically adjusting its radial dimensions, the structure maintains anchoring stability through initial expansion while avoiding continuous outward force that would cause harmful increases in aortic annulus diameter.
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 allows for effective replacement of the native aortic valve with a smaller transcatheter heart valve, reducing the risk of dislodgement and damage, and providing a safer, less invasive treatment option for patients who cannot undergo open-heart surgery.
Implementation Method 1
a shape-memory support structure and grabbing mechanisms, such as micro-anchors, that can be radially compressible and self-adjustable
Data Source
AI summary
Methods and devices for treating defective heart valves are disclosed herein. In one exemplary embodiment, a transcatheter heart valve includes an expandable shape memory stent and a valve member supported by the stent. A plurality of micro-anchors can be disposed along an outer surface of the stent for engaging native tissue. The transcatheter heart valve can be configured to be advanced into a dilated valve annulus via a balloon catheter. The balloon can be inflated to expand the transcatheter heart valve from a collapsed diameter to an over-expanded diameter such that the micro-anchors engage tissue along the surrounding valve annulus. After engaging the tissue, the balloon can be deflated and the shape memory stent can retract or recoil toward its predetermined recoil diameter. As the stent recoils, the surrounding tissue is pulled inward by the stent such that the diameter of the valve annulus is reduced.