Implantable Frame Retainer for Recapturable THV Deployment
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Solution Overview
Problem
Transcatheter heart valves (THVs) are often too small to securely implant in larger native valves or deployment sites, such as enlarged aortas, and lack a suitable seat for secure placement, leading to challenges in transcatheter valve implantation.
Innovation Solution
A radially expandable and compressible stent frame with connecting posts and a delivery device featuring a retainer mechanism, allowing controlled deployment and recapture of the frame, ensuring precise implantation and minimizing jumping from the sheath.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard-sized transcatheter heart valve is used in a larger native valve, then the valve can be implanted using conventional delivery systems, but the valve cannot expand sufficiently to secure the implantation site, leading to potential complications
Solution Approach 1:
The frame is nested within an expandable cage structure, where the cage provides additional radial expansion capability. The frame and cage are configured to expand together, with the cage extending beyond the frame to provide enhanced anchoring in larger native valves while maintaining compatibility with conventional delivery systems.
Solution Approach 2:
The invention adds a radial dimension to the expansion capability by introducing the expandable cage that extends beyond the frame. This additional radial dimension allows the implant to achieve greater diameter than a frame-only design, enabling secure anchoring in enlarged aortas while maintaining the same delivery catheter size.
2Reliability
If the valve is expanded to a larger size to fit larger native valves, then the valve can secure the implantation site better, but the delivery catheter must be larger and more invasive
Solution Approach 1:
The frame is nested within the expandable cage, allowing both structures to be delivered through a single catheter system. The cage is compressed within the delivery catheter alongside the frame, then expanded radially to provide additional anchoring without requiring a larger delivery catheter.
Solution Approach 2:
The implant transitions from a compressed delivery state to an expanded deployed state through controlled radial expansion. The expandable cage provides dynamic expansion capability, allowing the implant to achieve larger final dimensions while maintaining a compact delivery profile through the catheter.
3Reliability
If the valve is expanded to a larger size to fit larger native valves, then the valve can secure the implantation site better, but the valve cannot be recaptured if mispositioned
Solution Approach 1:
The expandable cage is pre-configured with a recapture mechanism that engages with the delivery catheter. Before deployment, the cage can be recaptured by re-engaging with the delivery catheter's recapture feature, allowing repositioning or retrieval if the initial implantation position is incorrect.
Solution Approach 2:
The implant maintains dynamic controllability through the recapture mechanism, allowing transition between deployed and recaptured states. The expandable cage's structural design enables it to be expanded for secure anchoring when correctly positioned, while also allowing recapture and repositioning if needed.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables secure and controlled deployment of transcatheter valves in larger native valves by allowing partial expansion and recapture, reducing the risk of improper implantation and material deformation.
Implementation Method 1
the frame can be expanded from a compressed delivery configuration to a deployed configuration
Implementation Method 2
The connecting post can include a body portion and a head portion affixed to an end of the body portion. The head portion can have a first edge extending outwardly of the body portion. The first edge can include a substantially flat portion that is substantially perpendicular to the body portion.
Data Source
AI summary
Embodiments of an implantable frame are disclosed. The frame can have a plurality of struts interconnected to each other to form a mesh structure that is radially expandable and compressible. The frame can have a connecting post extending from an end of the frame. The connecting post can have a body portion and a head portion affixed to an end of the body portion. The head portion can have a first edge extending outwardly of the body portion. The first edge can have a substantially flat portion that is substantially perpendicular to the body portion.