Articulated Valve Prosthesis with Snap-Lock Fins
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Solution Overview
Problem
Current devices, such as the MITRACLIP™, are ineffective in simultaneously catching all three flaps of the tricuspid valve, leading to limited effectiveness in treating tricuspid regurgitation and an increased risk of tricuspid stenosis when multiple devices are used.
Innovation Solution
A prosthesis with angularly spaced triples of fins, deployable from a catheter, designed to catch and retain all three flaps of the tricuspid or mitral valve, utilizing a snap-lock mechanism and shape memory or elastic materials for automatic opening and secure fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single catching device with two arms (MITRACLIP™) is used, then the device can be easily introduced through a catheter, but it is unable to simultaneously catch all three flaps of the tricuspid valve
Solution Approach 1:
The prosthesis is divided into multiple independent arms (at least three arms) that can be deployed separately from a single catheter. Each arm is equipped with fins for catching valve flaps, allowing simultaneous engagement of multiple flaps while maintaining catheter-based delivery.
Solution Approach 2:
Multiple arms are nested within a single catheter in a collapsed configuration during delivery. Upon deployment, the arms extend radially outward to assume their functional positions, enabling the device to transition from a compact deliverable state to an expanded functional state.
2Reliability
If multiple MITRACLIP™ devices are implanted to improve valve continence, then more flaps can be caught, but the risk of tricuspid stenosis increases significantly
Solution Approach 1:
Multiple catching arms are integrated into a single prosthesis device that is delivered through one catheter. This unified structure allows simultaneous engagement of multiple valve flaps in a coordinated manner, improving continence while avoiding the complications of multiple separate interventions.
Solution Approach 2:
The prosthesis is designed with multiple arms that can simultaneously engage multiple valve flaps, making a single device capable of performing the function that previously required multiple devices. This multi-functional approach addresses both the need for improved continence and the need to avoid stenosis.
3Ease of operation
If the prosthesis arms are kept collapsed during delivery, then the device can be introduced through a catheter, but the fins cannot automatically open to catch the valve flaps
Solution Approach 1:
The fins are designed to be dynamic rather than static. They transition from a collapsed, longitudinal configuration during delivery to an open, radial configuration upon deployment. This dynamic transformation is enabled by elastic or shape memory materials that allow the fins to automatically open when released from the catheter.
Solution Approach 2:
The physical state of the fins changes from a constrained, linear arrangement during delivery to an expanded, radial arrangement during operation. This parameter change is achieved through the use of elastic or shape memory materials that respond to environmental conditions (such as temperature or mechanical release) by automatically changing their configuration.
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 prosthesis effectively maintains all valve flaps in a secure configuration, reducing regurgitation while minimizing the risk of stenosis, allowing for a more durable and effective repair compared to existing methods.
Implementation Method 1
The fins (4, 6) are made of an elastic material or a shape memory material so as to be able to open automatically from a retracted configuration, in which they are extended longitudinally along an external wall respectively of the second tubular support (3) and of the third tubular support (5), to an open configuration, in which they are open radially away from the external wall respectively of the second tubular support (3) and of the third tubular support (5), as soon as they are free to unfold.
Implementation Method 2
The fins (4, 6) are made of an elastic material or a shape memory material so as to be able to open automatically from a retracted configuration, in which they are extended longitudinally along an external wall respectively of the second tubular support (3) and of the third tubular support (5), to an open configuration, in which they are open radially away from the external wall respectively of the second tubular support (3) and of the third tubular support (5), as soon as they are free to unfold.
Data Source
AI summary
A prosthesis, left in the patient's heart to repair the tricuspid or mitral valve, is made to simultaneously hold all three tricuspid valve flaps, or the two mitral valve flaps, to keep them fully extended in the plane of the valve and to assume a final configuration as in the common surgical procedure. A device for repairing a tricuspid or mitral valve including such a prosthesis is also disclosed.