Mitral Valve Stabilizer Arms for Leak Prevention
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Solution Overview
Problem
Current methods for treating dysfunctional mitral valves are invasive, require skilled surgeons, and face challenges due to the mitral valve's irregular shape and lack of radial support, leading to issues with prosthetic fit and stability, and are associated with risks such as perivalvular leaks and potential collapse of the aortic tract.
Innovation Solution
An interventional device with subannular and supra-annular arms that can be advanced intravascularly to stabilize mitral valve leaflets and facilitate the placement of a prosthetic valve, featuring a deployable configuration that grips the leaflets and annulus, with locking mechanisms to secure the device and reduce the risk of leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If traditional surgical approaches (open thoracotomy) are used for mitral valve replacement, then the procedure can be performed with established techniques, but the patient experiences significant pain and requires long recovery periods
Solution Approach 1:
A delivery catheter is introduced as an intermediary device to deliver the prosthetic valve and stabilizing structures through the vasculature to the mitral valve position, avoiding the need for open thoracotomy and enabling percutaneous access
Solution Approach 2:
The traditional mechanical surgical approach requiring large incisions and direct manual manipulation is replaced with a catheter-based delivery system that uses fluid dynamics and remote deployment mechanisms to achieve valve replacement
2Ease of manufacture
If a cylindrical prosthetic valve is implanted in the mitral position, then the valve can be easily manufactured and deployed, but gaps are left in the commissural regions causing perivalvular leaks
Solution Approach 1:
The stabilizing structures are configured with asymmetric geometries including curved arms and extensions that specifically target and conform to the irregular mitral annulus shape and commissural regions, rather than using symmetric cylindrical forms
Solution Approach 2:
Different portions of the stabilizing structures have different functions: some arms provide general annular support while others with extensions specifically target commissural regions for enhanced sealing, creating localized quality variations to address specific anatomical challenges
3Device complexity
If radial support is not provided to the mitral annulus during prosthetic valve implantation, then the procedure is simpler, but the aortic tract may collapse causing serious complications
Solution Approach 1:
Stabilizing structures are deployed in advance of the prosthetic valve to provide preliminary radial support to the mitral annulus and surrounding tissue, preventing aortic tract collapse before the valve is fully implanted
Solution Approach 2:
The stabilizing structures act as a cushioning framework that is established beforehand to protect the aortic tract from collapse during the valve implantation process, absorbing mechanical stresses before they can cause damage
4Stability of the object's composition
If the mitral valve annulus is enlarged due to heart disease, then the heart muscle dilates as a compensatory mechanism, but the valve leaflets fail to coapt properly causing regurgitation
Solution Approach 1:
The stabilizing structures are designed to be deployable and adjustable, transitioning from a compressed delivery configuration to an expanded functional configuration that dynamically adapts to the enlarged annulus dimensions
Solution Approach 2:
The device changes its physical parameters including radius, arm span, and engagement force to match the enlarged annulus dimensions, providing appropriate support despite the altered anatomical parameters caused by heart disease
Data Source
AI summary
Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.