Actively Controllable Mitral Valve Implant with Adjustable Lattice
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Solution Overview
Problem
Current transcatheter mitral valve replacement (TMVR) techniques face challenges such as poorly fitting valve sizes, inability to reposition the implant during deployment, and pre-determined final expanded diameter, leading to issues like leakage and migration, which are not adequately addressed by existing systems.
Innovation Solution
The development of actively controllable mitral valve implants with a self-expanding and forcibly expanding lattice structure, featuring a valve trampoline and adjustable stent lattice, allowing for reversible expansion and contraction, and a self-expanding implant skirt to ensure a fluid-tight seal, accommodating the unique D-shaped mitral valve annulus and providing optimal flow and durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a self-expanding lattice structure is used for the mitral valve implant, then the valve can be delivered percutaneously in a compressed state and expanded at the desired position, but the final expanded diameter is pre-determined and cannot be adjusted, leading to poor fitting and leakage
Solution Approach 1:
The lattice structure transitions from a static pre-determined expansion design to a dynamic system with adjustable expansion. The lattice is designed to be expandable beyond its pre-defined shape through the application of external forces via control wires, allowing the final diameter to be adjusted according to the patient's anatomical requirements while maintaining percutaneous delivery capability.
Solution Approach 2:
The valve implant is divided into distinct functional components: a self-expanding lattice structure for initial deployment and a separate control wire system with jack screws for additional expansion. This segmentation allows the valve to first achieve basic expansion through the lattice's memory shape, then be further adjusted by the control mechanism, providing both ease of delivery and adaptability.
2Device complexity
If the lattice is made entirely self-expanding, then the device is simpler and requires fewer control mechanisms, but the expansion cannot be controlled or adjusted during deployment, causing migration and paravalvular leakage
Solution Approach 1:
The control wires extend from the implant location to the environment outside the patient and terminate at an electronic delivery control handle, providing feedback and control over the lattice expansion. This allows the operator to monitor and adjust the expansion process in real-time, ensuring proper placement and preventing migration and leakage while maintaining reasonable device complexity.
Solution Approach 2:
The lattice is pre-configured with a heat-set initial shape that provides a baseline expansion, but the design anticipates the need for further adjustment by incorporating adjustable expansion devices. This preliminary self-expansion reduces the complexity needed compared to a fully controlled system, while the added control mechanism ensures reliability by allowing fine-tuning during deployment.
3Adaptability or versatility
If control wires are connected to jack screws to expand and contract the lattice, then the valve can be repositioned and adjusted during deployment, but the device complexity increases with multiple control mechanisms
Solution Approach 1:
The control wire system serves multiple functions: it expands the lattice beyond its pre-defined shape, contracts the lattice for repositioning, and maintains control over the valve's final position. By making this single control system multi-functional, the patent achieves repositioning capability without proportionally increasing device complexity, as one control mechanism accomplishes what would otherwise require multiple separate systems.
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
The solution enables precise placement and secure fixation of the mitral valve implant, reducing leakage and migration risks, and accommodating various annulus sizes, thereby improving valve function and longevity by eliminating continuous outward force on the native tissue.
Implementation Method 1
collapsible transcatheter prosthetic heart valves that can be percutaneously introduced in a compressed state on a catheter and expanded to a functional size at the desired position
Implementation Method 2
a set of adjustable expansion devices that place respective forces upon the lattice to elastically and/or plastically deform the lattice... One example of the expansion devices is a set of jack screws that are controlled by rotating drive wires
Implementation Method 3
place respective forces upon the lattice to elastically and/or plastically deform the lattice to a size that is even greater than the pre-defined shape
Data Source
AI summary
A method of implanting a replacement mitral valve can include expanding a replacement mitral valve to a first expanded configuration. The replacement mitral valve can include a force-expanding mitral valve lattice and a self-expanding valve trampoline lattice. The mitral valve lattice has an inflow end portion and an outflow end portion, and the valve trampoline lattice is attached to the outflow end portion of the mitral valve lattice. The method can also include rotating a plurality of jack screws connected to the mitral valve lattice. The jack screws can be configured to expand the mitral valve lattice from the first expanded configuration to a second expanded configuration.