Mitral Annulus Resizing Implant With Helical Anchors
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Solution Overview
Problem
Mitral valve regurgitation, which occurs when the mitral valve leaflets fail to close properly, leading to leakage and adversely affecting cardiac function, is currently treated invasively through open-heart surgery, posing significant risks.
Innovation Solution
A minimally invasive method and device using a tubular implant with piercing members and a transitionable diameter configuration to engage and reshape the mitral valve annulus, reducing the valve's cross-sectional area by applying expansive forces to the upper diameter, facilitated by a delivery system with rotatable drivers and helical anchors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery with cardiopulmonary bypass is used to repair mitral valve, then mitral regurgitation can be corrected, but the procedure becomes highly invasive with inherent risks
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that uses a catheter-based approach. The implantable device is delivered through a catheter inserted via peripheral vessels, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart, thus substituting a less invasive mechanical delivery system while achieving the same therapeutic goal
Solution Approach 2:
The patent introduces a catheter as an intermediary device that facilitates the delivery of the mitral valve repair implant without requiring direct surgical access to the heart. The catheter serves as a mediator that transports the implant through the bloodstream to the target location, enabling minimally invasive delivery while maintaining therapeutic effectiveness
2Reliability
If a tubular implant with piercing members is used to engage the mitral valve annulus, then the valve can be reshaped to reduce regurgitation, but the device complexity increases
Solution Approach 1:
The patent divides the implant into distinct functional segments: a tubular body for structural support and diameter transition, and separate piercing members for tissue engagement. This segmentation allows each component to perform its specific function optimally while simplifying the overall design and deployment sequence, as the piercing members can be independently actuated from the tubular body
Solution Approach 2:
The patent incorporates a dynamic diameter transition mechanism in the tubular body that allows the implant to change from a first structural configuration (upper diameter smaller than lower diameter) to a second structural configuration (upper diameter larger than lower diameter) through application of expansive force. This dynamic adaptability enables the implant to engage the mitral valve annulus effectively and reshape it to reduce regurgitation while maintaining structural integrity
Data Source
AI summary
Systems, devices and methods for resizing a valve annulus are described. An implant is delivered proximate a mitral valve, the implant comprising a tubular body and a plurality of piercing helical anchors, the tubular body comprising an proximal diameter and a distal diameter. Tissue proximate the mitral valve is engaged by rotating the plurality of anchors with corresponding rotational drivers. The tubular body may be transitioned from a first structural configuration having the proximal diameter smaller than the distal diameter to a second structural configuration having the proximal diameter larger than the distal diameter.