Mitral Valve Frame Anchoring via Moveable Restraints
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Solution Overview
Problem
Current methods for treating mitral valve disease, such as surgical ring implantation and catheter-based techniques, are invasive and do not provide a durable solution for reducing mitral regurgitation, necessitating a less invasive and more effective heart valve replacement method.
Innovation Solution
A heart valve replacement device featuring an implantable frame with expandable anchors and a valve mechanism, designed for minimally invasive delivery via catheterization, which includes a tubular frame with struts and anchors to secure the device within the mitral valve annulus, and a seal to prevent leakage, allowing for secure positioning and blood flow regulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical ring implantation is used to treat mitral valve disease, then the mitral annulus diameter is reduced allowing proper leaflet coaptation, but the procedure requires invasive open chest surgery with high surgical risk
Solution Approach 1:
The surgical ring implantation procedure is segmented into a minimally invasive catheter-based delivery system. The frame is divided into expandable struts with separate anchors that can be independently deployed through venous access, eliminating the need for open chest surgery while maintaining the annulus-reducing function.
Solution Approach 2:
A catheter-based delivery system acts as an intermediary between the physician and the implantation site. The frame and anchors are delivered through a catheter inserted via venous access in the groin, allowing the surgical ring to be implanted without direct surgical exposure of the heart chambers.
2Object-affected harmful factors
If catheter-based techniques are used to treat mitral valve disease, then surgical risk is reduced, but the durability and effectiveness in reducing mitral regurgitation is insufficient
Solution Approach 1:
The patent merges the advantages of both surgical and catheter-based approaches by combining the durable annulus-reducing function of surgical rings with the minimally invasive delivery of catheter-based techniques. The expandable frame with anchors provides surgical-level durability while being delivered through a catheter.
Solution Approach 2:
The frame is designed to be expandable from a compressed delivery configuration to an expanded implanted configuration. This dynamic transformation allows the frame to be delivered through a small catheter and then expanded to provide the full annulus-reducing function of a surgical ring.
3Shape
If the frame is expanded to reduce the mitral annulus diameter, then leaflet coaptation is improved, but the frame requires secure anchoring to prevent migration
Solution Approach 1:
Anchors are deployed into the mitral valve annulus tissue before the frame is expanded. This preliminary anchoring action secures the frame in position, preventing migration during the expansion process and ensuring stable positioning of the reduced annulus.
Solution Approach 2:
The frame incorporates anchors made of materials and structures designed for tissue engagement. The anchors feature piercing elements and embedding configurations that provide secure attachment to the annulus tissue, combining the frame's shape-changing capability with stable positioning.
4Stability of the object's composition
If anchors are used to secure the frame in the mitral valve annulus, then frame stability is improved, but the delivery system complexity increases
Solution Approach 1:
The anchors are nested within the frame structure during delivery. The anchors can be stored in a compressed or retracted state within the delivery catheter and frame assembly, then deployed outward or extended after the frame is positioned in the mitral valve annulus.
Solution Approach 2:
The anchors are designed to be movable relative to the frame, transitioning from a retracted or compressed delivery configuration to an extended or deployed implanted configuration. This dynamic design allows the anchors to be stored compactly during delivery and then deployed to provide stable anchoring.
Data Source
AI summary
Features for a heart valve device are described. The device may include a frame with anchors configured to secure the device to tissue. The frame may include a flared end or skirt for additional securement of the implanted device. The device may include a seal such as a barrier and/or cuff for preventing leakage. The device may contract for endovascular delivery of the device to the heart and expand for securement within the heart, such as the within the native mitral valve annulus. The device may include a replacement valve. The valve may have leaflets configured to re-direct blood flow along a primary flow axis.