Two-Component Mitral Valve Delivery for Flow-Preserving Fixation
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Solution Overview
Problem
Existing transcatheter mitral valve replacement (TMVR) devices face challenges such as high delivery profile, potential for blood flow obstruction, thromboemboli formation, and difficulty in securing the device without impinging on the left ventricular outflow tract (LVOT), making them unsuitable for less invasive procedures.
Innovation Solution
A dual-component stent-valve system with a first component that expands via a mechanical or self-expanding mechanism, securely attached to the mitral annulus using barbs activated by a torus balloon, and a second component with replacement leaflets, positioned to minimize blood stagnation and thromboemboli formation by extending into the left atrium and avoiding LVOT obstruction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a standard dilation balloon is used to activate barbs, then the TMVR device can be secured to the mitral annulus, but blood flow through the mitral annulus is blocked during inflation causing temporary oxygen deprivation to the brain
Solution Approach 1:
The balloon is divided into multiple separate balloons, each responsible for activating a specific barb. This segmentation allows selective and controlled activation of barbs while maintaining blood flow pathways between the balloons, preventing complete obstruction of blood flow during activation.
Solution Approach 2:
The patent introduces a fluid-filled balloon as an intermediary mechanism to activate barbs indirectly. The balloon applies localized pressure to push barbs outward without requiring direct mechanical manipulation, and the fluid-filled nature allows controlled deformation while maintaining patency of surrounding vessels.
2Reliability
If barbs are activated prior to full apposition of the stent against the mitral annulus, then the barbs can engage the annulus, but the stent-valve frame cannot be positioned uniformly around the perimeter of the mitral annulus
Solution Approach 1:
The barbs are pre-formed and positioned on the stent frame in a compressed state, ready for activation. The delivery system pre-positions the stent-valve assembly such that when the balloon activates the barbs, the stent is already in the correct location and orientation, ensuring uniform positioning around the mitral annulus perimeter.
Solution Approach 2:
The barbs are designed to be dynamically activatable - they remain retracted during delivery and can be pushed outward by balloon inflation. This dynamic characteristic allows the stent to first achieve proper positioning through delivery catheter control, then secure engagement through barb activation, ensuring both uniform positioning and reliable attachment.
3Ease of operation
If the delivery profile of the TMVR device is reduced for transvascular delivery, then less invasive access is achieved, but the device becomes more difficult to position and secure without migration
Solution Approach 1:
The TMVR device is designed with a nested structure where the stent-valve frame is contained within a delivery catheter in a compressed, low-profile state for easy transvascular delivery. Upon deployment, the stent expands outward while barbs activate to engage the mitral annulus, providing secure positioning. The nested design allows transition from compact delivery to expanded functional state without migration.
4Reliability
If a stent is expanded indiscriminately outwards in the mitral valve, then the valve can be replaced, but the left ventricular outflow tract (LVOT) may be blocked by the anterior mitral valve leaflet
Solution Approach 1:
The stent is designed with non-uniform expansion characteristics - the expansion is localized and controlled to engage the mitral annulus at specific locations without indiscriminate outward expansion. The barbs are positioned to engage the annulus tissue specifically, while the stent body maintains appropriate spacing from the LVOT, preventing blockage of the outflow tract while achieving secure valve replacement.
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 system allows for secure, low-profile delivery and positioning of the mitral valve replacement without obstructing blood flow, reducing thromboemboli risk and ensuring unimpeded blood flow through the left atrium and ventricle.
Implementation Method 1
a torus balloon, both of which are balloon expandable via pneumatic pressure
Implementation Method 2
The stent-valve assembly is self-expanding, although it may include one or more balloon expandable stents
Data Source
AI summary
A mitral valve system comprising a first docking component and a second valvular component that are delivered via a single delivery catheter. The first component is located distal to the second component and provides a detachable rail to allow the second component to accurately position and lock with the first component. The first component has fixation members that are activated by either by a torus balloon or via fiber that does not restrict blood flow during delivery or during fixation member activation.