Mitral Valve Docking Device Deployment for Secure Prosthetic Valve Anchoring
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Solution Overview
Problem
Existing technologies face challenges in effectively anchoring and retaining prosthetic heart valves at non-circular positions like the mitral valve, due to cyclic loads, anatomical variations, and the risk of perforation during implantation, leading to issues such as valve dislodgment, leaks, and damage.
Innovation Solution
A delivery device is used to deploy a coiled or helical anchoring device that forms a circular or cylindrical docking site at the native valve position, secured via a transcatheter approach, allowing for minimally invasive implantation of prosthetic valves using self-expanding, balloon, or mechanical expansion methods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a circular prosthetic valve is used for mitral valve replacement, then the valve structure can be simplified and manufactured more easily, but the valve cannot effectively anchor at the non-circular mitral annulus position
Solution Approach 1:
A docking device is introduced as an intermediary component between the circular prosthetic valve and the non-circular mitral annulus. The docking device includes a frame with expansion elements that can be positioned at the mitral annulus, providing a circular anchoring structure that matches the prosthetic valve geometry while adapting to the non-circular anatomical site.
Solution Approach 2:
The docking device is divided into multiple expandable elements or segments that can be independently deployed at different locations around the mitral annulus. This segmentation allows the device to conform to the non-circular anatomy while providing a circular overall structure for valve attachment.
2Reliability
If the mitral valve is subjected to cyclic loads during ventricular contraction, then normal valve function is maintained, but the prosthetic valve may dislodge or fatigue over time
Solution Approach 1:
The docking device utilizes a circular or cylindrical geometric structure that provides uniform distribution of mechanical stresses around the mitral annulus. This curved, symmetric design helps resist the cyclic loading forces during heart contraction, preventing stress concentration that could lead to dislodgment or fatigue.
Solution Approach 2:
The docking device is deployed and anchored to the mitral annulus before the prosthetic valve is implanted. This preliminary anchoring establishes a stable, pre-positioned foundation that can withstand cyclic loads throughout the valve's service life, preventing subsequent dislodgment.
3Reliability
If puncturing is performed to anchor the valve at the mitral position, then better anchoring can be achieved, but unintended perforation and patient injury may occur
Solution Approach 1:
The docking device serves as an intermediary that distributes anchoring forces across a broader area of the mitral annulus rather than concentrating them at single puncture points. This distributed anchoring mechanism reduces the risk of perforation while maintaining secure valve retention.
Solution Approach 2:
The docking device incorporates flexible elements that can conform to the mitral annulus geometry without requiring aggressive puncturing. The flexible nature of the device allows it to adapt to the anatomical structure while providing sufficient anchoring through distributed contact rather than forceful penetration.
4Reliability
If a helical or coiled anchoring device is used, then secure anchoring at the mitral position can be achieved, but the device complexity increases
Solution Approach 1:
The docking device incorporates expandable elements that can transition from a compressed delivery state to an expanded anchoring state. This dynamic capability allows the device to be delivered through a catheter in a compact form and then expand at the target site to provide secure anchoring, reducing the need for complex helical or coiled structures.
Solution Approach 2:
The docking device is designed to nest within itself or within the delivery catheter in a compressed state, with expandable elements that can be deployed sequentially. This nesting capability simplifies the overall device structure by eliminating the need for complex external anchoring mechanisms like helical coils.
Data Source
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Figure 3
Figure 4A~4B
AI summary
Systems and methods usable in delivering a docking device to a native valve of a patient's heart. A distal region of a delivery catheter can be positioned in an atrium of the heart and a distal tip can be positioned at or near a commissure of the native valve. The docking device can be located within the delivery catheter. A pusher, such as a pusher wire or tube, of a pusher tool can be advanced distally through the delivery catheter, wherein the pusher can push the docking device along within the delivery catheter. The docking device can be connected to the pusher tool by a line, such as a suture. A member of the pusher tool can be rotatable to change the amount of the suture extending from the pusher tool.