Mitral Valve Implant With Leaflet Clamp And Balloon Occlusion
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Solution Overview
Problem
Existing treatments for mitral regurgitation, such as surgical valve repair or replacement, are invasive and risky, while percutaneous solutions face challenges like calcification issues and difficulty in precise implantation, leading to inefficiencies in closing the mitral valve during systole.
Innovation Solution
A percutaneously implantable heart valve device with a clamp and inflatable balloon that attaches to a leaflet, allowing for precise closure of the mitral valve during systole, using a pusher element to pivot the clamp and a shape memory support tab for adjustment, with a locking mechanism to secure the clamp in place.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical valve repair or replacement is performed, then effective treatment of mitral regurgitation is achieved, but patient risk and invasiveness increase
Solution Approach 1:
A percutaneous delivery system acts as an intermediary to deliver the valve implant through the vascular system rather than requiring direct surgical access to the heart. The catheter-based delivery system allows the implant to be positioned at the mitral valve site through peripheral vessels, eliminating the need for thoracotomy or sternotomy and significantly reducing surgical trauma and patient risk.
Solution Approach 2:
The patent replaces the traditional mechanical surgical approach with a less invasive percutaneous delivery mechanism. Instead of using surgical instruments requiring open chest access, the system uses a catheter-based delivery system that can be inserted through peripheral vessels and navigated to the heart, substituting complex surgical mechanics with simpler vascular access mechanics.
2Object-affected harmful factors
If percutaneous solutions are used, then invasiveness is reduced, but implantation precision and calcification handling become problematic
Solution Approach 1:
The delivery system incorporates preliminary positioning and alignment mechanisms that prepare the implant for precise deployment before actual implantation. The system allows for pre-positioning of the implant at the target site, verification of correct orientation, and adjustment before releasing the implant from the delivery catheter, ensuring precision despite the percutaneous approach.
Solution Approach 2:
The patent employs dynamic adjustment capabilities in the delivery system that allow real-time modification of implant position and orientation during the procedure. The system includes movable components and adjustable mechanisms that enable the operator to fine-tune the implant placement dynamically, adapting to anatomical variations and calcification patterns encountered during the procedure.
3Object-affected harmful factors
If existing percutaneous methods are used, then surgical risk is reduced, but ability to handle calcification and ensure complete closure deteriorates
Solution Approach 1:
The implant design incorporates local quality variations with different structural characteristics at different zones. The valve structure includes regions with enhanced flexibility for navigating calcified areas and regions with rigid support for ensuring complete closure. The delivery system also has differentiated zones for engagement, navigation, and secure deployment, allowing it to handle calcification locally while maintaining overall closure effectiveness.
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 device effectively reduces mitral regurgitation by adjusting to the valve's morphology, minimizing invasiveness and risks, and ensuring secure closure with minimal blood reflux.
Implementation Method 1
a shape memory support tab (20) attached to the balloon (12), said support tab comprising a shape memory material exhibiting, in a first temperature range, a first shape state in which the support tab is folded back and, in a second temperature range, a second shape state in which the support tab is deployed
Data Source
AI summary
Implant (10) for a heart valve comprising two leaflets, particularly a mitral valve (MV), the implant (10) comprising: a clamp (11) comprising a body (13) and a jaw (14) rotationally hinged with the body (13) to pivot between an open position and a closed position in which the body (13) and the jaw (14) are able to clamp a first leaflet among the heart valve leaflets, so as to attach the implant (10) onto the first leaflet,a movement device (41, 42) comprising a pusher element (41), the movement device being configured to move the jaw (14) relative to the body (13) from the open position to the closed position or vice versa, when the pusher element (41) is pushed by a rod (101), and a balloon (12) attached to the clamp (11) and configured to close at least partially an open portion (O1) remaining between the heart valve (MV) leaflets during systole, when the implant (10) is attached to the first leaflet, so as to limit a reflux of blood through said open portion (O1) remaining during systole.