Percutaneous Mitral Valve Replacement Anchoring and Sealing
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Solution Overview
Problem
Dilation of the mitral valve annulus leads to incomplete coaptation of valve leaflets, resulting in regurgitation and decreased cardiac output, necessitating a prosthetic valve replacement solution that effectively anchors and seals a prosthetic valve within the native valve environment.
Innovation Solution
A system involving guide members, commissural anchors, and a collapsible prosthetic valve support with a cylindrical and annular element configuration, allowing minimally-invasive delivery and anchoring to the native valve, using sealing balloons, helices, and grasping elements to ensure secure positioning and sealing between the prosthetic and native valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted to replace a dilated native mitral valve, then regurgitation is reduced and cardiac output is improved, but the complexity of the device and procedure increases significantly
Solution Approach 1:
The prosthetic valve is nested within a valve support structure that includes a cylindrical element and an annular element. The cylindrical element is positioned within the ventricle while the annular element rests on the annulus, creating a nested configuration that provides both anchoring and sealing functions in a single integrated device
Solution Approach 2:
The valve support is divided into two distinct segments: a cylindrical element for ventricular anchoring and an annular element for annular support. This segmentation allows each element to perform its specific function optimally while working together as a unified system
2Reliability
If traditional open-heart surgery is used for valve replacement, then reliable valve implantation is achieved, but patient recovery time and surgical risk increase
Solution Approach 1:
The valve support structure is designed to be expandable from a compressed delivery state to an expanded implanted state. The cylindrical and annular elements can be dynamically deployed after percutaneous insertion, transitioning from a low-profile delivery configuration to a fully functional implanted configuration
Solution Approach 2:
A delivery catheter serves as an intermediary device that facilitates the percutaneous insertion of the compressed valve support. The catheter guides the device through the vasculature to the heart and then retracts, allowing the valve support to self-expand or be expanded by a deployment mechanism
3Ease of operation
If the prosthetic valve is delivered percutaneously, then patient trauma is reduced, but precise positioning and anchoring of the valve becomes more difficult
Solution Approach 1:
The cylindrical element is pre-configured with anchoring features such as barbs or hooks that engage with the ventricular myocardium. The annular element is pre-shaped to conform to the annulus geometry, allowing the device to self-anchor upon deployment without requiring complex real-time adjustment procedures
4Reliability
If the native valve leaflets are left in place during prosthetic valve implantation, then valve sealing may be improved, but the risk of endocarditis and thrombus formation increases
Solution Approach 1:
The cylindrical element of the valve support is designed to push the native valve leaflets away from the prosthetic valve interface. This extraction of the native leaflets from the critical sealing zone eliminates the pocket where blood stasis, thrombus, and infection could develop, while the annular element maintains the sealing function at the annulus level
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 2A~2B
AI summary
Apparatus and methods are described including a prosthetic valve support (40) configured to be placed at a patient's native atrioventricular valve annulus. The valve support defines an annular element (44) that defines an inner cross-sectional area thereof. An expandable prosthetic valve (80) is placed into the patient's ventricle, the prosthetic valve including an expandable frame (79) and prosthetic valve leaflets (82) coupled to the frame. When the frame is in a non-constrained state thereof, a cross-sectional area of the frame, along at least a given portion L of the frame's length, is greater than the cross-sectional area defined by the annular element. The prosthetic valve is couplable to the prosthetic valve support at any location along the portion, by the frame being expanded when the location along the portion is aligned with the annular element. Other applications are also described.