Segmented Mitral Spacer for Minimally Invasive Valve Repair
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Solution Overview
Problem
Current surgical methods for correcting mitral regurgitation, a condition where the mitral valve fails to close properly, require invasive open-heart procedures that are risky and typically recommended only when the patient's ejection fraction drops below 60% or the left ventricle enlarges to 45 mm, leading to decreased blood flow and pressure.
Innovation Solution
A mitral valve implant system comprising a spacer with individual segments that can be assembled and secured to the native coronary tissue, allowing for percutaneous or transluminal delivery and expansion to correct valve regurgitation, featuring a shaft with anchor portions and deformable segments that can be delivered through a smaller catheter, interacting with the mitral valve to prevent backflow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgical procedures are used to correct mitral regurgitation, then the valve can be repaired or replaced, but the patient faces severe risks and complications
Solution Approach 1:
The mitral valve implant is divided into multiple segments including a discoid body portion, a shaft, and an anchor portion. These segments can be assembled separately and delivered through a catheter, allowing minimally invasive implantation while maintaining the structural integrity needed for effective valve repair
Solution Approach 2:
The implant components are designed to be nested within each other during delivery - the discoid body portion is positioned at the distal end of the shaft, which is inserted through the catheter. The anchor portion is deployed from the shaft to secure the implant in place, enabling complex implantation through a small access point
2Reliability
If a large spacer is used to correct mitral regurgitation, then valve function is improved, but the delivery system becomes too complex to deliver through small vessels
Solution Approach 1:
The spacer is divided into multiple compressible segments that can be collapsed into a compact configuration for delivery through small catheters, then expanded at the implantation site to provide the necessary structural support for valve correction
Solution Approach 2:
The implant structure is designed to transition from a compressed delivery state to an expanded functional state. The discoid body portion and shaft can be compressed for delivery and then expanded to form the final spacer structure that effectively corrects mitral regurgitation
Data Source
AI summary
A heart valve implant according to one embodiment may include a shaft extending generally along a longitudinal axis of the heart valve implant having at least one anchor configured to be coupled to a first end of the shaft. A spacer may include a plurality of individual segments each including at least one passageway configured to be disposed about the shaft. The plurality of individual segments may define an outer surface of the spacer which is configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position. The plurality of individual segments may each having a length and at least one cross-section dimension no larger than an internal cross-section of a lumen of a delivery catheter.