Removable Actuator Valve Annulus Implant
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Solution Overview
Problem
Current endoluminal mitral valve annuloplasty techniques face challenges with device fatigue, potential for fracture, and thrombus formation due to chronic contact with cardiac tissue, as well as a high implant profile that increases the risk of migration and embolic complications.
Innovation Solution
A low-profile valve annulus implant system with a removable actuator that includes a shaft and collar mechanism, allowing for expansion or contraction of the frame, which is anchored to the valve annulus and then partially or fully removed post-anchoring, reducing the implant's profile and minimizing contact with cardiac tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional endoluminal annuloplasty device is used, then the mitral valve annulus can be repaired, but the device has a high implant profile that increases the risk of migration and embolic complications
Solution Approach 1:
The actuator is designed to be removable from the frame after deployment. The collar travels along the shaft to engage or disengage the struts, and can be completely removed from the implant, leaving only the frame and anchors in place. This extraction of the actuator eliminates the source of migration risk while preserving the therapeutic effect of the deployed frame.
Solution Approach 2:
The implant system is divided into separable components: the frame with anchors that remain permanently implanted, and the actuator that is temporarily attached for deployment and adjustment then removed. This segmentation allows the therapeutic frame to stay in place while the potentially problematic actuator is taken out, resolving the contradiction between repair effectiveness and migration risk.
2Adaptability or versatility
If the actuator remains permanently attached to the frame, then the frame can be adjusted, but the device is subject to chronic stress from cardiac muscle palpitation causing fatigue and fracture
Solution Approach 1:
The frame is adjusted to its final configuration during the deployment procedure while the actuator is still attached. The collar is actuated to expand or contract the frame as needed, and then the actuator is removed. This preliminary action of adjusting the frame before removing the actuator allows the frame to be configured correctly while avoiding long-term exposure to cardiac stresses that would cause fatigue.
Solution Approach 2:
The actuator is completely removed from the implant after the frame has been deployed and adjusted. This extraction eliminates the actuator from the chronic stress environment of the heart, preventing fatigue and fracture while the frame remains permanently adjusted in place. The frame retains its adjusted configuration without the weakened actuator components.
3Stability of the object's composition
If the actuator remains permanently attached, then the frame configuration can be maintained, but the implant profile remains high increasing contact with cardiac tissue and thrombus formation
Solution Approach 1:
The actuator is removed from the implant after deployment, significantly reducing the overall implant profile. This extraction eliminates unnecessary surfaces that would otherwise contact cardiac tissue and promote thrombus formation. The frame maintains its stable configuration without the actuator, achieving both configuration stability and reduced thrombus risk.
Solution Approach 2:
The actuator serves its purpose during deployment and adjustment, then is discarded by being removed from the implant. This temporary use followed by removal allows the frame to maintain its configuration while eliminating the actuator's harmful presence that would increase thrombus formation risk during chronic implantation.
Data Source
AI summary
Various embodiments of an implant delivery systems including at least one removable actuator to reshape a valve annulus are described. The systems may use the removable actuator to customize annular reshaping at a treatment site and withdraw the actuator from the treatment site following custom reshaping to provide a low profile annuloplasty implant.