Mitral Valve Annulus Resizing via Helical Anchor Penetration
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Solution Overview
Problem
Current methods for treating mitral valve regurgitation, such as open-heart surgery, are invasive and carry significant risks, and there is a need for a less invasive solution to effectively reduce the size of the mitral valve annulus to prevent leakage.
Innovation Solution
A tubular implant with a frame and helical anchors that can transition from a smaller to a larger diameter configuration, allowing the anchors to penetrate and engage the mitral valve annulus, reducing the valve's size through an expansive force applied to the upper portion, thereby reducing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery is performed to repair the mitral valve, then the mitral valve can be effectively repaired, but the procedure is highly invasive and carries significant risks
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that uses a catheter-based approach. The implant is delivered through a catheter inserted via a peripheral vessel, eliminating the need for sternotomy and cardiopulmonary bypass. This substitution of the delivery mechanism reduces invasiveness while maintaining repair effectiveness.
Solution Approach 2:
The patent introduces a transcatheter delivery system as an intermediary between the operator and the target mitral valve. The delivery catheter serves as a mediator that transports the implant to the precise location without requiring direct surgical access to the heart, thereby reducing surgical trauma and risks.
2Manufacturing precision
If a tubular implant with helical anchors is used to reduce mitral valve annulus size, then the valve annulus can be effectively resized, but the device structure becomes complex
Solution Approach 1:
The implant is segmented into multiple functional components: a tubular body for structural support, helical anchors for tissue engagement, and an expandable mechanism for size adjustment. This segmentation allows each component to perform its specific function optimally while enabling precise control over the valve annulus resizing.
Solution Approach 2:
The implant incorporates a dynamic expandable mechanism that allows the tubular body to transition between compressed and expanded states. This dynamic capability enables the device to be delivered in a compact form through the catheter and then expanded at the target site to achieve the precise sizing needed for effective mitral valve repair.
3Object-affected harmful factors
If the implant is delivered through a catheter, then the procedure becomes minimally invasive, but the delivery system complexity increases
Solution Approach 1:
The implant is designed to be nested within the delivery catheter in a compressed state. The tubular body and helical anchors are contained within the catheter lumen during delivery, allowing the entire system to be introduced through a peripheral vessel. After deployment, the implant is expanded and the delivery catheter is withdrawn, eliminating the need for complex external manipulation mechanisms.
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
This approach allows for a minimally invasive procedure to resize the mitral valve annulus, reducing the risk of complications and effectively addressing mitral regurgitation by enabling proper closure of the valve leaflets.
Implementation Method 1
a plurality of helical anchors connected to the tubular body proximate the distal diameter of the frame, the plurality of helical anchors configured to be rotated by a plurality of rotatable drivers to advance the plurality of helical anchors distally relative to the frame and penetrate the heart valve annulus
Implementation Method 2
transitioning the tubular body from a first structural configuration to a second structural configuration by application of an expansive force to the tubular body proximate the upper diameter
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
Systems, devices and methods for resizing a valve annulus are described. An implant (910) is delivered proximate a mitral valve, the implant comprising a tubular body (940) and a plurality of piercing helical anchors (930), the tubular body comprising an proximal diameter and a distal diameter. Tissue proximate the mitral valve is engaged by rotating the plurality of anchors with corresponding rotational drivers. The tubular body may be transitioned from a first structural configuration having the proximal diameter smaller than the distal diameter to a second structural configuration having the proximal diameter larger than the distal diameter.