Multi-Part Prosthetic Mitral Valve Frame for Catheter Delivery
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Solution Overview
Problem
There is a need for minimally invasive techniques to replace the mitral valve, as existing catheter-based procedures are not applicable due to the distinct anatomical differences between the aortic and mitral valves, particularly the presence of chordae tendinae, and many patients with defective mitral valves are denied treatment due to age and co-morbidities.
Innovation Solution
A prosthetic mitral valve apparatus with a radially compressible and self-expandable frame, ventricular anchors, and an atrial sealing member that secures the valve within the native mitral valve annulus, utilizing ventricular anchors to capture leaflets and an atrial sealing member to prevent paravalvular leakage, allowing for minimally invasive implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is performed to replace the mitral valve, then the valve replacement can be effectively performed, but the invasiveness and surgical risks are high
Solution Approach 1:
The prosthetic valve system is divided into multiple components: a delivery catheter, a self-expandable valve frame, anchoring mechanisms, and a valve prosthesis. This segmentation allows the valve to be delivered through a minimally invasive transvascular approach rather than requiring open heart surgery, while still achieving effective valve replacement through the coordinated function of these separate components
Solution Approach 2:
A delivery catheter serves as an intermediary device that transports the compressed prosthetic valve through the blood vessels to the implantation site. The catheter enables minimally invasive delivery by acting as a conduit that bypasses the need for open surgical access, while the self-expandable frame and anchoring mechanisms ensure secure implantation once delivered
2Object-affected harmful factors
If catheter-based procedures are used for aortic valve replacement, then invasiveness is reduced, but the procedures are not applicable to mitral valve due to anatomical differences
Solution Approach 1:
The prosthetic valve design incorporates local adaptations for mitral valve anatomy, including a specific frame configuration with radial expansion capability and anchoring mechanisms that account for the presence of chordae tendineae. The valve frame includes features such as a compressed state for delivery and an expanded state for function, with anchoring elements positioned to engage with mitral valve tissue while accommodating the unique subvalvular apparatus
Solution Approach 2:
The valve frame undergoes parameter changes from a compressed state during delivery to an expanded state during implantation. This transformation allows the valve to be delivered through a minimally invasive catheter in a compact form, then expand to its functional dimensions at the implantation site, adapting to the mitral valve anatomy while maintaining the benefits of reduced invasiveness
3Reliability
If a self-expandable frame is used, then secure anchoring is achieved, but the device complexity increases
Solution Approach 1:
The valve frame is designed with self-expanding capabilities using shape memory materials or elastic recovery properties. Once deployed from the delivery catheter, the frame automatically expands to its functional configuration and anchors itself to the mitral valve tissue without requiring additional deployment mechanisms or complex actuation systems, achieving secure anchoring while limiting the increase in device 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 secure and effective replacement of the mitral valve with reduced invasiveness, addressing the challenges of chordae tendinae and improving patient access by minimizing surgical risks and complications.
Implementation Method 1
a frame having a main body and at least one ventricular anchor coupled to and disposed outside of the main body. The main body is radially compressible to a radially compressed state for delivery into the body and self-expandable from the compressed state to an expanded state
Implementation Method 2
self-expandable from the compressed state to an expanded state
Data Source
AI summary
A prosthetic heart valve includes a multi-part frame having a first annular body and an anchor component that includes a second annular body circumscribing the first annular body. The first annular body includes a plurality of struts arranged in a lattice pattern and defining a lumen. The anchor component further includes one or more ventricular anchors extending from the second annular body toward an inflow end portion of the first annular body. A fabric layer is disposed on an inner surface of the first annular body and sutured to the struts. A valve structure including three leaflets is disposed within the lumen and inlet ends of the leaflets are sutured to the fabric layer. The multi-part frame is radially compressible for delivery within a sheath of a delivery catheter and is self-expandable for deployment within an annulus of a native valve.