Percutaneous Mitral Valve Replacement Anchoring and Sealing
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Solution Overview
Problem
Current methods for mitral valve replacement are invasive, complex, and often ineffective in reducing mitral regurgitation (MR) without causing negative physiological consequences such as stenosis or atrial fibrillation, particularly in patients with secondary or functional MR, where the risks of intervention outweigh the benefits.
Innovation Solution
A percutaneous or minimally invasive mitral valve replacement system that includes an anchoring structure and an artificial valve, utilizing a staged approach with an anchor element, sealing element, and valve element, which secures the valve without disrupting native valve function and maintains LV geometry, allowing for reliable and repeatable procedure with reduced invasiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current invasive methods for mitral valve replacement are used, then the valve can be replaced, but the procedure is invasive and complex with negative physiological consequences such as stenosis or atrial fibrillation
Solution Approach 1:
The replacement valve is divided into multiple functional elements: an anchoring structure for securement, a sealing structure for preventing regurgitation, and a valve structure for flow control. These segmented components can be delivered and deployed separately through catheters, reducing the invasiveness of the procedure while maintaining effectiveness in treating mitral regurgitation without causing stenosis or atrial fibrillation
Solution Approach 2:
A sealing structure acts as an intermediary element between the anchoring structure and the native valve tissue. This sealing component prevents direct contact between the rigid anchoring structure and the soft tissue, reducing the risk of tissue damage, atrial fibrillation, and other harmful physiological consequences while maintaining the reliability of mitral regurgitation reduction
2Reliability
If surgical correction is performed early in the disease process, then the beneficial effects of eliminating MR are achieved, but the risk of surgery in healthy patients is high
Solution Approach 1:
The traditional mechanical surgical approach (open chest, sternotomy, cardiopulmonary bypass, direct suture placement) is replaced with a less invasive mechanical system that delivers the valve replacement through catheters via venous access. This substitution maintains the beneficial effects of eliminating mitral regurgitation while dramatically reducing the procedural risks and invasiveness associated with traditional surgery
3Object-affected harmful factors
If percutaneous or minimally invasive mitral valve replacement is performed, then invasiveness is reduced, but the procedure must be reliable and repeatable
Solution Approach 1:
The anchoring structure is designed with pre-formed engagement features and delivery mechanisms that ensure proper positioning and secure attachment to the mitral valve apparatus before the valve structure is deployed. This preliminary anchoring action ensures the reliability and repeatability of the percutaneous procedure by establishing a stable foundation that can consistently withstand physiological forces
Solution Approach 2:
The valve system incorporates adjustable parameters including the expansion force of the anchoring structure, the sealing pressure of the sealing elements, and the opening area of the valve structure. These parameter changes allow the procedure to be adapted to different patient anatomies and physiological conditions, ensuring reliability and repeatability across diverse clinical scenarios while maintaining minimal invasiveness
Data Source
Figure 1A~1B
Figure 2A~2E
Figure 3~5
AI summary
Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.