Compressible Mitral Valve Prosthesis With Cuff-and-Tether Anchoring
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Solution Overview
Problem
Current transcatheter mitral valve replacement technologies face challenges due to the complexity of the native mitral valve apparatus and the difficulty in anchoring the replacement prosthesis, leading to higher morbidity and the need for open-heart surgery, which is poorly tolerated by elderly patients.
Innovation Solution
A compressible prosthetic heart valve designed for deployment into a beating heart using a transcatheter delivery system, featuring a self-expanding tubular stent with a cuff and tethers for anchoring, which can contour to the mitral annulus and accommodate physiological heart movements, minimizing perivalvular leak and ensuring proper seating during the cardiac cycle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open heart surgery is used for valve replacement, then complete valve replacement can be achieved, but morbidity and mortality risk increase significantly
Solution Approach 1:
The patent replaces the mechanical open-heart surgery system with a transcatheter delivery system. The valve is delivered through a catheter inserted via the femoral artery, eliminating the need for thoracic surgery, heart-lung machine, and open chest procedure, thus reducing morbidity and mortality risks while achieving complete valve replacement
Solution Approach 2:
The patent introduces a delivery catheter as an intermediary device to transport the prosthetic valve from the femoral artery to the mitral valve position. This intermediary system enables minimally invasive delivery without requiring direct surgical access to the heart, thereby reducing procedural risks
2Ease of operation
If transcatheter mitral valve replacement is attempted, then minimally invasive approach is achieved, but anchoring difficulty increases due to mitral valve complexity
Solution Approach 1:
The patent divides the anchoring function into multiple independent components: a cuff for circumferential sealing and engagement with the annulus, and separate tethers for longitudinal positioning and stabilization. This segmentation allows each component to address specific anchoring challenges independently, simplifying the overall anchoring mechanism while maintaining secure fixation
Solution Approach 2:
The patent applies different anchoring characteristics to different regions: the cuff provides circumferential sealing and radial engagement at the annular level, while the tethers provide longitudinal stabilization extending into the ventricle. This local differentiation of anchoring functions addresses the complex geometry of the mitral valve apparatus more effectively than a uniform anchoring design
3Reliability
If rigid valve housing is used for transcatheter aortic valve replacement, then anchoring is facilitated, but adaptability to mitral valve anatomy is reduced
Solution Approach 1:
The patent employs a self-expanding stent structure that transitions from a compressed delivery configuration to an expanded functional configuration at the valve site. This dynamic expansion allows the valve to adapt to the specific anatomical dimensions of the mitral annulus while maintaining structural integrity and anchoring stability, overcoming the limitation of rigid housings
Solution Approach 2:
The patent utilizes shape memory alloy materials that change their physical state or dimensions in response to temperature or mechanical stimulation. This parameter change enables the stent to expand from a compressed delivery state to a functional state that conforms to the mitral annulus geometry, providing both adaptability and anchoring stability
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
Enables minimally invasive mitral valve replacement with reduced morbidity and mortality by allowing deployment in a closed heart, providing compliance and secure anchoring, thus avoiding the need for extra-corporeal circulation and open-heart surgery.
Implementation Method 1
a self-expanding tubular stent having a cuff and tether attachment structures
Implementation Method 2
capable of deformation without fracture
Data Source
Figure 1
Figure 2A~2D
Figure 3A~3E
AI summary
This invention relates to the design and function of a compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.