Coiled Heart Valve Docking for Mitral Valve Anchoring
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Solution Overview
Problem
The challenge of effectively anchoring and retaining prosthetic heart valves, particularly at non-circular sites like the mitral valve, due to large cyclic loads and complex anatomy, leads to issues such as regurgitation and instability during transcatheter implantation.
Innovation Solution
A coiled anchor or docking device is used to create a stable, circular docking site at the native valve position, allowing for secure implantation of prosthetic valves through transcatheter methods, with features like self-expansion, balloon expansion, or mechanical expansion to ensure retention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted at a non-circular site like the mitral valve, then the valve can be placed at the desired location, but the anchoring stability is compromised due to large cyclic loads and complex anatomy
Solution Approach 1:
A docking device is introduced as an intermediary component between the prosthetic valve and the native mitral annulus. This docking device creates a circular anchoring structure that simplifies the complex non-circular anatomy, providing a stable interface for valve implantation while accommodating the natural annular geometry
Solution Approach 2:
The docking device is divided into multiple segments or struts that can be independently deployed and positioned. This segmentation allows the device to adapt to the complex three-dimensional geometry of the mitral annulus while collectively forming a stable circular structure for anchoring
2Ease of manufacture
If a circular prosthetic valve is used for replacement, then the valve structure is simplified and manufacturing is easier, but the valve does not fit well at non-circular sites like the mitral annulus
Solution Approach 1:
The docking device serves as a mediator that allows a standard circular prosthetic valve to be accurately positioned at a non-circular mitral annulus. The docking device's struts are configured to match the native annular geometry while presenting a circular interface for the prosthetic valve
Solution Approach 2:
The docking device employs asymmetric strut configuration to accommodate the non-circular mitral annulus geometry. The struts are positioned at specific angles and lengths to match the natural anatomy, creating symmetry only at the valve interface where needed
3Ease of operation
If transcatheter implantation is used, then the procedure is less invasive, but effective anchoring and retention of the valve is difficult due to large cyclic loads
Solution Approach 1:
The docking device is deployed and positioned at the mitral annulus before the prosthetic valve is implanted. This preliminary action creates a pre-formed anchoring structure that is ready to receive and securely retain the valve, ensuring adequate retention force is established prior to valve insertion
Solution Approach 2:
The docking device employs curved or arc-shaped struts that conform to the natural curvature of the mitral annulus. This curved geometry provides optimal mechanical engagement with the annular tissue, enhancing retention strength while maintaining a minimally invasive transcatheter approach
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 coiled anchor provides a robust anchoring mechanism, reducing regurgitation and ensuring stable placement of prosthetic valves at non-circular sites like the mitral annulus, enhancing the success of transcatheter heart valve replacement procedures.
Implementation Method 1
features like self-expansion, balloon expansion, or mechanical expansion to ensure retention
Implementation Method 2
features like self-expansion, balloon expansion, or mechanical expansion to ensure retention
Implementation Method 3
The coiled anchor provides a robust anchoring mechanism, reducing regurgitation and ensuring stable placement
Data Source
AI summary
Systems and methods for delivering a docking device configured to receive a prosthetic valve are disclosed. A system can include a delivery catheter and a pusher device disposed in the delivery catheter and a docking device comprising a plurality of turns when in a coiled shape and having a proximal end portion and a distal end portion opposite the proximal end portion, where a retrieval line extends through a central lumen of the pusher device and is coupled to the proximal end portion of the docking device. The docking device is configured to move between a straightened shape when the docking device is arranged within the delivery catheter and the coiled shape after the docking device is pushed out of the docking device by the pusher device.