Personalized Aortic Valve Prosthesis with Self-Expanding Mesh
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Solution Overview
Problem
Traditional surgical methods for replacing native valves, such as the aortic valve, require major surgery and have challenges with accurately delivering and securely anchoring prosthetic valves, often resulting in perivalvular leaks.
Innovation Solution
A self-expanding, anatomically conformal prosthetic valve is fabricated using a method that involves creating a digital data set from patient-specific images, forming a mandrel, applying a mesh that matches the valve anatomy, and heat-treating it to bias the mesh for expansion, ensuring secure anchoring and minimizing leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used to replace native valves, then valve replacement can be achieved, but major surgery is required and recovery period is lengthy
Solution Approach 1:
The invention changes the physical state and delivery parameters of the prosthetic valve from a large, rigid structure requiring open surgery to a compressed, flexible structure that can be delivered through minimally invasive catheter-based approaches. The valve is designed to expand from a low-profile delivery configuration to its functional expanded configuration at the implantation site, fundamentally changing the delivery parameters to enable percutaneous access.
Solution Approach 2:
The prosthetic valve is designed with a nested structure where the valve components are contained within a delivery catheter system. The valve frame and leaflets are compressed within the catheter lumen during delivery, similar to nested dolls, allowing the large valve structure to be delivered through a small access point and then deployed at the target site.
2Ease of operation
If traditional prosthetic valves are delivered minimally invasively, then surgery is less invasive, but accurate delivery and secure anchoring become difficult
Solution Approach 1:
The prosthetic valve is pre-shaped and pre-configured with specific geometric features including non-circular cross-sections and asymmetric designs that provide inherent orientation and positioning cues. The valve frame includes pre-formed engagement structures and anchoring elements that automatically align with the native valve anatomy during deployment, eliminating the need for complex real-time alignment maneuvers.
Solution Approach 2:
The invention incorporates radiopaque markers and imaging-compatible materials throughout the valve structure that enable real-time visualization and tracking during the minimally invasive delivery process. These markers appear on fluoroscopic and other imaging modalities, allowing operators to precisely track the valve's position and orientation as it is delivered and deployed, ensuring accurate placement without requiring open surgical exposure.
3Stability of the object's composition
If traditional prosthetic valves are anchored securely, then valve stability is improved, but perivalvular leaks still occur
Solution Approach 1:
The prosthetic valve employs local quality variations in its frame structure, with different regions having different densities, flexibilities, and engagement characteristics. The valve frame includes specialized sealing zones with enhanced radial force and conformability that locally adapt to the irregularities of the native valve annulus, while other regions provide structural support and anchoring. This localized differentiation of mechanical properties enables simultaneous secure anchoring and leak prevention.
Solution Approach 2:
The valve construction utilizes composite material structures combining metals with different elastic moduli, polymer coatings, and fabric layers with varying properties. The frame may combine rigid sections for structural integrity with more compliant sections for sealing and anchoring. These composite materials provide a combination of strengths, flexibilities, and sealing characteristics that prevent perivalvular leaks while maintaining stable anchoring.
4Ease of manufacture
If a standardized prosthetic valve is used, then manufacturing is simplified, but anatomical conformity is reduced
Solution Approach 1:
The prosthetic valve is designed as a segmented or modular structure where the frame is composed of multiple discrete elements or sections that can be independently formed and then assembled. This segmentation allows each segment to be manufactured using standardized processes, while the combination of segments creates a customizable overall geometry that can be tailored to specific patient anatomies through selective assembly or post-manufacturing adjustment.
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 allows for precise, minimally invasive delivery and secure anchoring of prosthetic valves that match the patient's anatomy, reducing the risk of perivalvular leaks and facilitating easier access for coronary interventions.
Implementation Method 1
heat treating the mesh while the mesh is disposed on the mandrel so that the mesh is biased to return to a shape matching the shape of the treatment site
Implementation Method 2
The self-expanding mesh has a collapsed configuration adapted to be delivered and an expanded configuration adapted to expand into engagement with the treatment site
Implementation Method 3
The self-expanding mesh has a collapsed configuration adapted to be delivered to the native valve treatment site and an expanded configuration adapted to expand the personalized prosthetic valve into engagement with the treatment site
Data Source
AI summary
A personalized prosthetic valve for implantation at a native valve treatment site includes a self-expanding mesh and a plurality of valve leaflets coupled to the mesh. The mesh may be delivered to the native valve in a collapsed configuration, and in an expanded configuration the mesh engages the native valve. The mesh in the expanded configuration is also personalized to match the treatment site, such that the outer mesh surface substantially matches the treatment site shape and size. The self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough. In the open configuration, blood passes through the prosthetic valve, and in the closed configuration, the plurality of leaflets are closer together and blood is prevented from flowing upstream through the prosthetic valve.