Mitral Valve Annulus Reshaping Tool
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Solution Overview
Problem
Current methods for mitral valve repair, such as using sutures and clips, are limited in effectively reshaping and supporting the mitral valve annulus, particularly in achieving a durable and anatomically appropriate contour.
Innovation Solution
A tool system with a reshaping element that can be directed between configurations to facilitate insertion and reshaping of the mitral valve annulus, combined with releasable fasteners and prostheses like annuloplasty rings, allows for temporary or permanent remodeling of the tissue annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sutures and clips are used for mitral valve repair, then the procedure is relatively simple to perform, but the ability to effectively reshape and support the mitral valve annulus is limited
Solution Approach 1:
The repair system is divided into multiple functional components: a delivery catheter for minimally invasive access, a reshaping element with specific geometric contours for annulus remodeling, and fastening mechanisms for securing the prosthesis. This segmentation allows each component to be optimized for its specific function while working together as an integrated system.
Solution Approach 2:
A reshaping element serves as an intermediary between the delivery system and the mitral valve annulus. This element is delivered through the catheter and deployed at the target site to provide the desired geometric reshaping of the annulus, mediating the transformation from the initial to the final anatomical configuration.
2Reliability
If a rigid reshaping element is used to provide stable support, then long-term durability is improved, but the ability to navigate through the body and conform to anatomical variations is reduced
Solution Approach 1:
The reshaping element transitions from a compressed, navigable state during delivery to an expanded, rigid support state after deployment. This dynamic transformation allows the element to adapt to anatomical variations during delivery while providing stable, durable support once positioned in the mitral valve annulus.
Solution Approach 2:
The reshaping element is nested within the delivery catheter in a compressed state, allowing it to navigate through the body's vasculature. Once positioned at the target site, the element is deployed outward from the catheter to assume its expanded functional configuration, providing rigid support while having previously adapted to the delivery pathway.
3Stability of the object's composition
If permanent fixation methods are used to secure the prosthesis, then long-term stability is achieved, but the ability to adjust the configuration during implantation is lost
Solution Approach 1:
The fastening mechanisms are designed to be deployed and secured in a predetermined sequence after the reshaping element is positioned. This preliminary positioning followed by sequential fixation allows the operator to adjust the configuration before committing to permanent attachment, ensuring optimal placement while achieving long-term 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 precise reshaping and long-term support of the mitral valve annulus, improving the durability and functionality of the valve by securely attaching prostheses with adjustable and flexible reshaping elements.
Implementation Method 1
a reshaping element on the distal end terminating in a distal tip and having a shape to remodel tissue adjacent a tissue annulus
Implementation Method 2
the actuator may be coupled to the actuator member for pulling or otherwise actuating the actuator member to cause the reshaping element to be directed from the first configuration to the second configuration
Implementation Method 3
the clips may be directed through tissue surrounding the annulus, and the clip released, whereupon the clips resiliently return towards the relaxed configuration
Data Source
AI summary
A tool for remodeling a tissue annulus includes an elongate handle and a reshaping element on a distal end of the handle. The reshaping element may be directable between a first configuration to facilitate direction through a tissue annulus, and a second curved configuration to remodel tissue adjacent the tissue annulus. The tool may be used for treating a tissue annulus within a patient's heart, e.g., by introducing the reshaping element through the tissue annulus, and manipulating the tool to reshape the tissue annulus substantially to a contour of the reshaping element. The reshaping element may support the tissue while a prosthesis is secured to the tissue annulus, or the reshaping element may itself be secured to the tissue annulus and released from the tool.