Partial Valve Prosthesis Framework for Mitral Annulus
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Solution Overview
Problem
Conventional cardiac-valve prostheses require invasive surgical procedures and poorly mimic the physiology of natural valves, leading to compromised health and complications, especially for valves like the mitral and tricuspid, which have unique anatomical shapes that traditional prostheses fail to replicate effectively.
Innovation Solution
Development of partial valve prostheses with frameworks made from shape memory materials like nickel titanium alloys and biocompatible materials, featuring securement features such as tines, clamps, and corkscrew anchors, designed for percutaneous delivery to follow the shape of native valve annuli and replace native leaflets, allowing for minimally invasive implantation and better physiological correlation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional cardiac-valve prostheses are used, then valve replacement can be achieved, but invasive surgical procedures are required and natural valve physiology is poorly mimicked
Solution Approach 1:
The valve prosthesis is divided into separate components: a delivery catheter, a collapsible valve body, and a framework. This segmentation allows the valve to be delivered through minimally invasive percutaneous access while maintaining the ability to replicate natural valve anatomy and function upon deployment.
Solution Approach 2:
The valve framework utilizes shape memory materials that change their physical state or dimensions in response to temperature or mechanical stress. This allows the framework to transition from a compressed delivery state to an expanded functional state, enabling minimally invasive delivery while maintaining structural integrity and physiological fidelity.
2Reliability
If conventional prostheses are used, then valve replacement is achieved, but the unique anatomical shapes of mitral and tricuspid valves are not replicated
Solution Approach 1:
The valve prosthesis incorporates region-specific features that match the unique anatomy of different valve types. The framework and leaflet configuration are customized to replicate the saddle-shaped mitral annulus and the tricuspid valve geometry, with varying local properties throughout the structure to preserve natural physiological characteristics.
Solution Approach 2:
The valve framework employs asymmetric designs that mirror the non-uniform anatomy of natural valves. Rather than using symmetric geometric forms, the prosthesis incorporates irregular shapes and non-uniform structural distributions to accurately replicate the complex three-dimensional geometry of mitral and tricuspid valves.
3Reliability
If traditional cardiac-valve prostheses are implanted, then valve function is restored, but adverse effects and complications increase
Solution Approach 1:
The valve prosthesis is designed to self-secure within the valve annulus through its framework structure and securement features, eliminating the need for additional surgical anchoring procedures. The device maintains its position and function through its own structural properties, reducing surgical complexity and associated complications.
Solution Approach 2:
The delivery catheter serves as an intermediary device that facilitates minimally invasive implantation by providing a controlled pathway for valve deployment. This intermediary mechanism enables percutaneous access while reducing direct surgical trauma to the patient's cardiovascular system.
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 partial valve prostheses enable minimally invasive, percutaneous replacement of native valve components, reducing adverse effects and improving patient outcomes by better mimicking the natural valve anatomy and function, suitable for conditions like mitral regurgitation and venous insufficiency.
Implementation Method 1
framework made from shape memory materials like nickel titanium alloys
Data Source
AI summary
A partial valve prosthesis includes a framework configured for following a shape of a portion of the native valve annulus when implanted into the native valve annulus, the framework including securement features for anchoring the framework to an inner periphery of the native valve annulus and retaining at least one leaflet configured to replace a corresponding one of the plurality of native leaflets; and at least one leaflet secured to the framework. Additional embodiments and methods are disclosed.