Heart Valve Regurgitation Implant With Localized Leaflet Augmentation
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Solution Overview
Problem
Current implant technologies for treating heart valve regurgitation, particularly functional mitral regurgitation, are inadequate and often disturb native valve dynamics, leading to poor long-term durability and are 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 at the regurgitant site, 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 heart valve regurgitation, then the regurgitation can be addressed, but the native valve dynamics are disturbed resulting in poor long-term durability
Solution Approach 1:
The implant is designed to provide localized augmentation only at the regurgitant site where needed, rather than replacing or significantly altering the entire valve structure. This focal approach allows the implant to address the specific defect while preserving the natural dynamics and function of the surrounding native valve tissue, thereby improving long-term durability without disturbing overall valve dynamics.
Solution Approach 2:
The implant acts as an intermediary component that bridges the regurgitant gap by augmenting the leaflet at the defect site. This intermediate structure provides the necessary support to eliminate regurgitation while allowing the native valve to maintain its natural motion patterns and hemodynamics, avoiding the harmful effects of more invasive replacement approaches.
2Ease of operation
If minimally invasive transcatheter approaches are used, then surgical risk is reduced for high-risk patients, but current implant technologies are inadequate and can disturb native valve dynamics
Solution Approach 1:
The implant delivers focused therapeutic action precisely at the regurgitant site through a minimally invasive transcatheter approach. By concentrating the treatment effect locally where the regurgitation occurs, the device achieves adequate treatment of the pathology while maintaining the minimally invasive benefit, avoiding both surgical trauma and the inadequacies of previous transcatheter devices.
Solution Approach 2:
The implant is designed to be dynamic and adaptable to the native valve's motion patterns rather than imposing a rigid structure. This allows the device to move with the valve during the cardiac cycle, preserving natural valve dynamics while providing effective regurgitation treatment through a minimally invasive approach.
3Reliability
If the implant augments the valve leaflet at the regurgitant site, then leaflet extension is provided and regurgitant gap is covered, but the implant must be lightweight to avoid disturbing valve dynamics
Solution Approach 1:
The implant concentrates its mass and structural support precisely at the regurgitant site where augmentation is needed, rather than distributing weight across the entire valve structure. This localized placement provides effective leaflet extension and gap coverage while minimizing the overall weight that could disturb native valve dynamics during cardiac motion.
Solution Approach 2:
The implant utilizes flexible, thin-film materials that provide the necessary structural support for leaflet augmentation while maintaining low weight. These flexible materials can conform to the native valve geometry and move with the valve during the cardiac cycle, effectively covering the regurgitant gap without adding excessive mass that would disrupt natural valve dynamics.
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.