Mitral Valve Prosthetic Spacer With Anchors for Leaflet Capture
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Solution Overview
Problem
There is a need for minimally invasive techniques to replace the mitral valve, as existing methods are not suitable due to the complex subvalvular apparatus of the mitral valve, particularly the chordae tendinae, leading to limited options for high-risk patients and elderly or frail individuals.
Innovation Solution
A prosthetic spacer and delivery system that includes a radially compressible and self-expandable frame with ventricular and atrial anchors, allowing secure implantation at the native mitral valve region, utilizing the ventricular anchors to capture native leaflets and the atrial sealing member to prevent paravalvular leakage, with delivery options from both the left ventricle and left atrium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is performed for mitral valve replacement, then the valve can be replaced effectively, but the procedure is highly invasive and prone to complications
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a catheter-based delivery system. The prosthetic valve is delivered through a catheter that can be inserted percutaneously or through a small incision, eliminating the need for sternotomy and cardiopulmonary bypass. The valve is then deployed at the target site using balloon expansion or self-expansion mechanisms, providing a minimally invasive alternative to traditional surgical replacement.
Solution Approach 2:
The patent introduces a catheter as an intermediary device to deliver the prosthetic valve to the mitral valve position. The catheter serves as a conduit that allows the valve to be transported through the bloodstream or heart chambers without requiring open surgical access. This intermediary approach enables percutaneous or minimally invasive delivery while maintaining the ability to effectively replace the defective valve.
2Object-affected harmful factors
If transvascular or transapical catheter techniques are used for aortic valve replacement, then invasiveness is reduced, but these techniques are not suitable for mitral valve due to complex subvalvular apparatus
Solution Approach 1:
The patent applies local quality by designing the prosthetic valve and delivery system specifically for the mitral valve's unique anatomy. The valve incorporates features such as anchors that engage with the mitral annulus or ventricular wall, and a frame structure that accommodates the subvalvular apparatus including chordae tendineae. The delivery catheter is designed to navigate to the mitral valve position and deploy the valve in the correct orientation, making the system adaptable to mitral valve-specific anatomical constraints.
Solution Approach 2:
The patent segments the prosthetic valve system into distinct functional components: a delivery catheter, a collapsible valve frame, anchors for securing the valve, and a sealing mechanism. This segmentation allows each component to be optimized for its specific function while working together as an integrated system. The modular design enables the valve to be delivered through a catheter and then deployed at the target site, adapting to the complex mitral valve anatomy.
3Object-affected harmful factors
If a prosthetic valve is delivered in a compressed state and expanded at the implantation site, then minimally invasive delivery is achieved, but the valve must be securely retained against displacement
Solution Approach 1:
The patent applies preliminary action by incorporating anchors on the valve frame that are designed to engage with the mitral annulus or ventricular wall before the valve is fully expanded. The delivery system is designed to position these anchors in advance, and upon deployment, the anchors secure the valve in place before the full expansion occurs. This preliminary anchoring prevents displacement during the expansion process and ensures stable positioning of the prosthetic valve.
Solution Approach 2:
The patent uses the nested doll principle by placing the collapsible valve frame within the delivery catheter in a compressed state. The valve frame is designed to be nested inside the catheter during delivery, allowing it to pass through the vasculature or heart chambers without obstruction. Upon reaching the implantation site, the valve frame is expanded from its compressed nested state to its functional size, achieving both minimally invasive delivery and secure retention.
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 secure and minimally invasive implantation of prosthetic valves at the mitral valve region, reducing trauma to native leaflets and improving retention, while addressing mitral regurgitation by remodeling the left ventricle and utilizing the native chordae tendineae for anchoring.
Implementation Method 1
the frame is radially expandable from a radially compressed state to an radially expanded state, the expanding causing a gap between the ventricular anchor and an outer surface of the main body to increase
Implementation Method 2
positioning the main body in the annulus of the native mitral valve and the ventricular anchor adjacent the ventricular side of a native mitral valve leaflet such that the leaflet is disposed in the gap between the ventricular anchor and the outer surface of the main body
Data Source
Figure 1
Figure 2~4A
Figure 4B~4D
AI summary
A prosthetic spacer (3000) for implanting at the native mitral valve region comprising: a spacer body (3004) configured for placement within the native mitral valve, a pair of ventricular anchors (3008, 3010) coupled to and disposed outside of the spacer body (3004) and a pair of atrial anchors (3012, 3014) coupled to and disposed outside of the spacer body (3004).