Low Profile Cardiac Valve via 15F Catheter Delivery
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Solution Overview
Problem
Existing transluminal cardiac valves require large bore catheters for delivery, which is problematic for individuals with small femoral arteries, and they also pose risks such as prion-vector transmission and thrombogenicity due to xenograft materials.
Innovation Solution
A low-profile transluminal cardiac valve designed for percutaneous delivery via a 15F or less catheter, incorporating biased cells and a polymer coating, with a single piece superelastic metal frame forming the valve body and leaflet structure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If existing transluminal cardiac valves are delivered through large bore catheters, then the valve structure can be sufficiently robust, but the procedure becomes problematic for individuals with small femoral arteries
Solution Approach 1:
The valve is divided into multiple modular components including a delivery catheter, a self-expanding frame, and separate leaflet assemblies. The frame is constructed from multiple biased cells that can be compressed independently for delivery, then self-assemble upon deployment, enabling robust construction that fits through small catheters
Solution Approach 2:
The valve components are nested within the delivery catheter in a compact configuration. The self-expanding frame collapses axially to fit within the catheter lumen, and the leaflets are positioned within the compressed frame structure, enabling delivery through 15F or less catheters while maintaining full valve functionality
2Ease of manufacture
If xenograft materials are used in cardiac valves, then the valve can be manufactured with established materials, but risks such as prion-vector transmission and thrombogenicity arise
Solution Approach 1:
The valve employs a composite construction combining a superelastic metal frame (such as nitinol) with biocompatible polymer coatings and synthetic leaflet materials. This eliminates xenograft tissues while maintaining manufacturability through established metal forming and polymer coating technologies
Solution Approach 2:
The valve uses synthetic, acellular materials that are manufactured as single-use disposable devices. The polymer-coated frame and synthetic leaflets eliminate biological variability and infectious risks associated with xenografts, while the standardized manufacturing process maintains ease of production
3Reliability
If a single piece superelastic metal frame is used, then the valve provides chronic fatigue resistance and durability, but the device complexity increases
Solution Approach 1:
The frame, leaflet support structure, and anchoring mechanisms are merged into a single piece superelastic metal construction. This unitary structure eliminates weak points from assembly joints and leverages the material's superelastic properties to provide chronic fatigue resistance while the integrated design actually reduces overall device complexity
Solution Approach 2:
The superelastic material properties are optimized to provide the required structural strength and fatigue resistance. By carefully controlling the material composition, wire diameter, and heat treatment parameters, the single-piece frame achieves the necessary mechanical performance without requiring additional reinforcing components that would increase complexity
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 efficient delivery of the cardiac valve through smaller catheters, reduces the risk of complications associated with xenograft materials, and provides chronic fatigue resistance and durability, capable of withstanding repetitive cycles without failure.
Implementation Method 1
a single piece superelastic metal frame forming the valve body and leaflet structure
Implementation Method 2
The in- and out-of-plane motion induced by application of a directional strain to the biased cell is capable, in turn, transferring the motive force from the biased cell to other structures joined, coupled, co-extensive, or communicating with the biased cell
Data Source
AI summary
Transluminally implantable cardiac valves configured for use in cardiac valve replacement and/or cardiac valve exclusion that are capable of percutaneous delivery on low-profile catheters having 15 French size or less. The implantable cardiac valves are fabricated of from a unitary metal material to form a lattice frame support having a main body portion and valve leaflet portion, and a plurality of elongate biasing arm members. A polymer coating or covering is disposed on the valve leaflet portion and the elongate biasing arm members and subtends space between adjacent pairs of elongate biasing arm members to form valve leaflet portions in which the elongate biasing arms and the polymer coating operate to share a mechanical load thereupon.