Steerable Mitral Valve Implant Delivery for Regurgitant Gap Coverage
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Solution Overview
Problem
Current implant technologies for treating functional mitral regurgitation (FMR) are inadequate and disturb native valve dynamics, leading to poor long-term durability, making them unsuitable for high-risk heart failure patients.
Innovation Solution
A steerable implant delivery system is used to deploy a lightweight implant that augments the valve leaflet, providing leaflet extension and covering the regurgitant gap in systole, while allowing unrestricted inflow in diastole, and can be adjusted to optimize positioning without damaging the native valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current implant technologies are used to treat functional mitral regurgitation, then regurgitation is addressed, but native valve dynamics are disturbed resulting in poor long-term durability
Solution Approach 1:
The implant is designed with a coaptation section that locally augments the valve leaflet at the regurgitant site, providing targeted support where needed while preserving the overall native valve dynamics and architecture. This localized approach allows the implant to correct regurgitation without disrupting the global function of the valve.
Solution Approach 2:
The implant acts as an intermediary structure between the valve leaflet and the regurgitant gap, providing a temporary or permanent scaffold that guides leaflet coaptation. This intermediary role allows the native valve to maintain its dynamics while the implant mediates the correction of regurgitation.
2Reliability
If implant is deployed to cover regurgitant gap, then regurgitation is reduced, but valve function may be compromised causing stenosis
Solution Approach 1:
The implant is designed to be dynamically adaptable, allowing the coaptation section to deform and conform with the valve leaflet during opening and closing cycles. This dynamic capability ensures that the implant maintains the regurgitant gap coverage while allowing unrestricted inflow during diastole, preventing stenosis.
Solution Approach 2:
The implant's mechanical properties are carefully tuned to change in response to physiological conditions. The coaptation section can alter its stiffness and compliance based on the cardiac cycle phase, providing support during systole while maintaining flexibility during diastole to prevent valve stenosis.
3Strength
If lightweight implant is used to avoid damage, then native valve is protected, but implant strength may be insufficient
Solution Approach 1:
The implant utilizes composite material structures that combine lightweight, biocompatible materials with reinforced sections. The coaptation section may incorporate stronger materials to provide structural support, while the overall implant remains lightweight to avoid damaging the native valve. This composite approach balances strength requirements with tissue preservation.
Data Source
AI summary
Embodiments described herein relate to an implant delivery system for delivering an implant for reducing heart valve regurgitation. The implant delivery system may include an implant catheter disposed in an inner lumen of a guide catheter. The implant catheter may include one or more hypotubes disposed therein, each hypotube configured to receive an elongate member such as a braided tether. A distal end of the implant catheter may be coupled to an implant holder configured to receive the implant. The implant holder may define one or more channels, each channel configured to receive a portion of a respective elongate member. The elongate members configured to couple the implant to the implant holder and transition the implant between configurations. The implant configured to be disposed around a portion of a leaflet of a heart valve to improve coaptation of the heart valve.