Articulated Valve Prosthesis with Shape Memory Arms
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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, particularly in cases of severe annular dilation, limiting their effectiveness in treating tricuspid regurgitation.
Innovation Solution
A device with shape memory arms that expand radially to form coplanar supports, allowing for the alignment and secure attachment of tricuspid or mitral valve flaps using suture threads, which can be cut and tied to maintain the flaps in a coplanar position, facilitating a more effective repair.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a standard catching device like MITRACLIP is used, then the device can be introduced through a catheter with a vascular approach, but it cannot simultaneously catch all three flaps of the tricuspid valve, especially in cases of severe annular dilation
Solution Approach 1:
The catching device is divided into multiple independent arms (at least three arms) that can be deployed simultaneously to engage different flaps of the tricuspid valve. Each arm can independently catch a flap, allowing the device to handle all three flaps concurrently, thereby resolving the limitation of catching only two flaps with standard devices.
Solution Approach 2:
The device incorporates arms that extend in different spatial dimensions from the catheter tip, allowing simultaneous engagement of multiple flaps that are distributed across the valve plane. This multi-dimensional arrangement enables the device to catch all three flaps even in severely dilated annuli where flaps are widely separated.
2Reliability
If the flaps are caught and tied together, then the regurgitation is reduced, but the flaps may not remain coplanar, affecting the quality of repair
Solution Approach 1:
The arms are designed with pre-formed coplanar geometry that guides the flaps into a coplanar arrangement before tying. By establishing the coplanar configuration in advance through the arm structure, the device ensures that when the flaps are tied together, they remain in the correct planar position for optimal repair quality.
Solution Approach 2:
The arms act as intermediary structures that maintain the coplanar relationship between flaps during the tying process. These arms serve as temporary scaffolding that holds the flaps in the desired configuration, ensuring coplanarity is maintained throughout the repair procedure.
3Reliability
If multiple arms are used to catch all flaps, then all flaps can be secured, but the device complexity increases
Solution Approach 1:
Each arm is designed to perform multiple functions: it serves as both the catching element for engaging a flap and as a structural support for maintaining coplanarity. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity despite the addition of multiple arms.
Solution Approach 2:
The multiple arms are nested within a single catheter structure, with each arm collapsible or foldable within the catheter lumen during delivery. This nesting arrangement allows the complex multi-arm device to be delivered through a relatively simple catheter, minimizing the apparent complexity during the delivery phase while providing full functionality upon deployment.
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 device ensures all flaps can be securely aligned and tied together, improving the repair of tricuspid regurgitation by maintaining the flaps in a coplanar position, enhancing the durability and effectiveness of the repair procedure.
Implementation Method 1
each arm is made of shape memory material and is configured to assume a radially expanded position with an elbow bend
Data Source
AI summary
A device for joining together the flaps of a tricuspid valve by joining them together while they arm kept aligned along the valve plane, is provided with a plurality of arms each having a first end fixed on a cylindrical proximal body and a second end fixed to a cylindrical distal body, in which each arm is made of shape memory material and is configured to assume a radially expanded position with an elbow bend so that, when they are in said radially expanded position with an elbow bend, they define as many radially oriented coplanar supports to support flaps of a tricuspid or mitral valve.