Coiled Valve Docking Structure for Non-Circular Heart Valve Anchoring
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Solution Overview
Problem
Existing transcatheter prosthetic heart valves face challenges in securely anchoring and retaining prosthetic valves at non-circular valve sites like the mitral and tricuspid valves due to their non-circular shape and the cyclic loads exerted by heart movement, leading to potential dislodgment and leakage.
Innovation Solution
A coiled docking device with flexible lumens and coils is used to create a stable, circular docking site at the native valve position, allowing for minimally invasive implantation and secure retention of prosthetic valves through balloon or self-expansion mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted at a non-circular valve site (mitral or tricuspid valve), then the valve can replace dysfunctional native valve, but the prosthetic valve may dislodge or leak due to non-circular shape and cyclic heart movement loads
Solution Approach 1:
The patent applies spheroidality by transforming the non-circular valve site into a circular configuration using a coiled docking device. The coil structure creates a circular anchoring zone that conforms to the prosthetic valve geometry, converting the geometric incompatibility between non-circular native valve sites and circular prosthetic valves into a stable interface. This resolves the contradiction by imposing a circular shape (the coil) at the implantation site to match the prosthetic valve while accommodating the underlying non-circular anatomy.
Solution Approach 2:
The patent employs parameter changes by utilizing the coil's ability to change its physical state from a compressed delivery configuration to an expanded deployed configuration. In the compressed state, the coil fits through a catheter for minimally invasive delivery; upon deployment, it expands to create a stable circular docking site that can securely retain the prosthetic valve against cyclic heart movement loads. This parameter change enables the same device to satisfy both delivery constraints and retention requirements.
2Reliability
If a stable circular docking site is created at a non-circular native valve position, then prosthetic valve retention is improved, but the device complexity increases due to coiled structure with lumens
Solution Approach 1:
The patent applies universality by designing the coiled docking device to perform multiple functions simultaneously: (1) the coil structure creates the circular docking site for prosthetic valve retention, (2) the lumens provide pathways for guidewires and delivery catheters, and (3) the entire assembly enables minimally invasive transcatheter delivery. This multi-functionality reduces device complexity by consolidating what would otherwise require separate components into a single integrated docking device.
Solution Approach 2:
The patent employs nesting by placing the lumens within the coil structure. The tubular body with lumens is positioned inside or along the coil, creating a nested configuration where the delivery catheter and guidewires can pass through the lumens while the coil provides the external circular anchoring structure. This nesting arrangement allows multiple functional elements to occupy the same space efficiently, reducing overall device complexity.
3Ease of operation
If minimally invasive implantation is used for prosthetic valve replacement, then patient recovery is improved, but secure anchoring at non-circular valve sites becomes more difficult
Solution Approach 1:
The patent applies the intermediary principle by introducing the coiled docking device as a mediator between the delivery catheter and the prosthetic valve. The docking device is first deployed from the catheter at the target valve site, creating a stable circular anchoring structure. Then the prosthetic valve is delivered through and deployed within this intermediate docking structure. This intermediary docking device enables secure anchoring at non-circular valve sites while maintaining the benefits of minimally invasive catheter-based delivery.
Solution Approach 2:
The patent employs preliminary action by deploying the coiled docking device before delivering the prosthetic valve. The docking device is first positioned and expanded to create the circular anchoring site, establishing a stable foundation. Only after this preliminary action is complete is the prosthetic valve delivered through the docking device and secured in place. This sequence ensures that the anchoring structure is ready to immediately support the prosthetic valve, combining minimally invasive delivery with secure retention.
Data Source
AI summary
Methods of implanting docking devices for prosthetic valves at a native heart valve include positioning a distal end of a delivery catheter into a first chamber of a heart, advancing a tubular body of a docking device from within the delivery catheter so that the distal end of the tubular body is advanced between native valve leaflets and positioned in a second chamber of the heart. The methods further include inserting a coil into a lumen of the docking device so that the tubular body adopts a configuration, releasing a proximal end of the docking device in the first chamber, inserting a replacement valve in an inner space of the docking device, and radially expanding the replacement valve until there is a retention force between the replacement valve and the docking device to hold the replacement valve in a stable position in the native valve.