Mitral Valve Prosthesis Self-Expanding Frame Support Arms
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Solution Overview
Problem
Current methods for mitral valve replacement are invasive and traumatic, often requiring heart arrest and cardiopulmonary bypass, making them unsuitable for inoperable or high-risk patients, and lacking consistency in outcomes.
Innovation Solution
A mitral valve prosthesis with a self-expanding frame and support arms that immobilize native leaflets, allowing for minimally invasive transapical, transatrial, or transseptal implantation, preventing obstruction, leaks, and migration, while mimicking native valve function and anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If standard mitral valve replacement is performed through open heart surgery, then complete valve replacement and reliable fixation are achieved, but patient trauma is severe and surgical risk is high
Solution Approach 1:
The prosthesis is divided into separate functional components: a self-expanding frame for structural support and positioning, support arms for anchoring to the mitral annulus, and a valve component for blood flow control. This segmentation allows each component to be optimized for its specific function while enabling minimally invasive delivery through catheter-based insertion.
Solution Approach 2:
The prosthesis components are nested within a delivery catheter system during insertion. The self-expanding frame is contained within the catheter, and upon deployment, the frame expands outward while the support arms extend to engage the mitral annulus. This nested configuration enables minimally invasive transapical, transatrial, or transseptal access while maintaining complete valve replacement capability.
2Ease of operation
If heart arrest and cardiopulmonary bypass are used for mitral valve replacement, then surgical access and valve implantation are facilitated, but patient risk and procedural complexity increase
Solution Approach 1:
The self-expanding frame automatically expands to its functional configuration upon deployment from the catheter, utilizing elastic memory or shape memory alloy properties. This self-service mechanism eliminates the need for complex external deployment mechanisms or manual manipulation during implantation, simplifying the procedural steps while ensuring reliable valve placement without requiring heart arrest or cardiopulmonary bypass.
3Ease of manufacture
If native leaflets are not addressed during valve replacement, then implantation is simpler, but leaflet obstruction and interaction with prosthetic leaflets occur
Solution Approach 1:
The support arms are integrated with the self-expanding frame to form a unified anchoring system. The support arms extend from the frame to engage the mitral annulus and simultaneously address the native leaflets by holding them away from the prosthetic valve orifice. This merging of functions allows the prosthesis to achieve both secure anchoring and native leaflet management in a single device, preventing obstruction while maintaining implantation simplicity.
4Device complexity
If the prosthesis does not prevent migration, then device structure is simpler, but valve position stability is compromised
Solution Approach 1:
The support arms are pre-configured in a compressed state within the delivery catheter and are designed to automatically engage the mitral annulus upon deployment. This preliminary configuration ensures that the anchoring function is activated immediately upon prosthesis placement, preventing migration before it can occur. The self-expanding frame simultaneously provides structural support, creating a stable anchored configuration without requiring additional active fixation mechanisms.
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
Enables safe, consistent, and reproducible minimally invasive mitral valve replacement, reducing trauma to the heart, accommodating both regurgitation and stenosis, and allowing for procedures by less experienced surgeons, thus improving patient outcomes and surgical feasibility.
Implementation Method 1
The prosthesis generally includes a self-expanding frame
Data Source
Figure 1A
Figure 1B
Figure 2
AI summary
A mitral valve prosthesis (100A) suited to be implanted transapically (i.e., through the apex of the heart), transatrially (i.e., through the left atrium of the heart), and transseptally (i.e., through the septum of the heart). The prosthesis generally includes a self - expanding frame (102) and two or more support arms (106). A valve prosthesis (118) is sutured to the self - expanding frame. Each support arm corresponds to a native mitral valve leaflet. At least one support arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The frame comprises an inflow region (116) having cross - sectional diameter larger than the annulus of the native mitral valve, an an outflow region (112) configured to expand within the native mitral valve annulus. Inflow and outflow regions are formed of a plurality of cells (103), usually diamond shaped.