Epicardial Pad Fixer Assembly for Mitral Valve Anchoring
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Solution Overview
Problem
Existing devices for anchoring prosthetic heart valves, such as those for the mitral valve, face challenges in delivering and securing tethers percutaneously due to large profiles and difficulty in achieving desired tension, and there is a critical need for effective sealing of cardiac puncture sites to prevent hemodynamic losses.
Innovation Solution
The use of an epicardial pad and a fixer assembly to secure a prosthetic valve by extending a tether through a minimally invasive opening at the heart's apex, with the epicardial pad being expandable and held in place by the fixer assembly to maintain the valve's position and seal the puncture site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If staples or fasteners are used to secure tethers to tissue, then anchoring is achieved, but the device profile becomes large and difficult to deliver percutaneously
Solution Approach 1:
The anchor device is nested within a delivery catheter in a compressed state, allowing percutaneous delivery through a small access site. Upon deployment, the anchor expands from its nested state to its functional size, achieving reliable tissue anchoring while maintaining a small delivery profile.
Solution Approach 2:
The anchor device transitions from a static compressed state during delivery to a dynamic expanded state during deployment. This dynamic transformation allows the device to achieve its full anchoring capability only when needed, resolving the contradiction between small delivery profile and large functional profile.
2Reliability
If suturing methods are used to secure tethers, then anchoring is achieved, but it becomes difficult to maneuver and secure with desired tension
Solution Approach 1:
The manual suturing process is replaced with a mechanically actuated anchor deployment system. The anchor is secured to tissue through a controlled mechanical expansion process that automatically achieves proper tensioning, eliminating the need for manual knot-tying and tension adjustment.
Solution Approach 2:
The anchor device self-secures to the tissue through its expansion mechanism, automatically achieving proper anchoring tension without requiring manual manipulation. The device performs its own securing function through the expansion action, eliminating the need for external suturing operations.
3Productivity
If direct puncture into ventricular wall is made, then prosthetic valve delivery is achieved, but sealing becomes critical to prevent hemodynamic losses
Solution Approach 1:
The seal is formed preliminarily through the deployment of the anchor device and epicardial pad before final valve seating. This preliminary sealing action prevents hemodynamic losses during the valve delivery and deployment process, addressing the critical sealing requirement before productivity concerns arise.
Solution Approach 2:
The epicardial pad acts as an intermediary element between the anchor device and the tissue. This intermediary component enhances the sealing function by distributing forces and creating a more effective seal at the puncture site, reducing hemodynamic losses while maintaining delivery efficiency.
Data Source
AI summary
Apparatus and methods are described herein for use in the delivery of a prosthetic mitral valve. In some embodiments, an apparatus includes a tether fixer assembly configured to engage an outside surface of a heart to secure a prosthetic heart valve in position within the heart. The fixer assembly defines a lumen configured to receive therethrough a tether extending from the prosthetic valve and a movable portion. The fixer assembly is movable between a first configuration, in which the movable portion is disengaged with the tether, and a second configuration in which the movable portion is engaged with the tether. The fixer assembly can be disposed against an epicardial pad positioned on the outside surface of the heart when in the second configuration to secure the prosthetic valve, the epicardial pad and tether in a desired position within the heart.