Left Atrial Appendage Occluder Cap Hinge Mechanism
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Solution Overview
Problem
Current implantable medical devices for occluding the left atrial appendage face challenges in deployment and redeployment, with issues related to tangling and damage during the process, and existing catheter systems are inefficient for delivering these devices effectively.
Innovation Solution
A two-piece medical device comprising a membrane-covered frame and a cap linked by a hinge mechanism, where the cap regulates deployment and protects retention members, allowing for controlled expansion and compression to facilitate secure placement and retrieval within a delivery catheter, utilizing superelastic materials for biasing into an expanded configuration and ensuring barb functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the device is designed to be deployed and recaptured multiple times, then the reliability of retention members is improved, but the device complexity increases due to the need for cap and hinge mechanisms
Solution Approach 1:
The device is divided into separate functional components: a frame structure, a cap component, and a hinge linkage system. This segmentation allows the retention members to be protected and controlled independently, enabling multiple deployment cycles while maintaining reliability.
Solution Approach 2:
The cap acts as an intermediary component that controls the deployment and recapture of the retention members. The hinge mechanism serves as a mediator between the cap and the frame, enabling controlled motion while protecting the retention members during storage and deployment.
2Strength
If the retention members are designed to penetrate tissue for secure anchoring, then the strength of device fixation is improved, but the risk of damage and tangling during deployment increases
Solution Approach 1:
The cap is designed to pre-protect the retention members during the deployment process. Before the retention members contact tissue, the cap controls their exposure and positioning, preventing premature tangling or damage. The hinge mechanism prepares the structure for controlled expansion, ensuring retention members deploy in the correct sequence and orientation.
Solution Approach 2:
The cap serves as an intermediary that mediates between the retention members and the external environment. It controls when and how the retention members are exposed, protecting them from damage during deployment while enabling secure tissue penetration when needed.
3Ease of operation
If the device is compressed within a delivery catheter for transport, then the ease of delivery is improved, but the risk of retention member damage increases
Solution Approach 1:
The device is designed with a nested configuration where the cap encloses the retention members during compression within the delivery catheter. This nesting protects the retention members from damage while maintaining compactness for easy delivery through the catheter system.
Solution Approach 2:
The cap acts as a protective intermediary between the retention members and the delivery catheter environment. It shields the retention members from mechanical damage during compression and transport while allowing controlled deployment when the device is released from the catheter.
4Ease of manufacture
If the device structure is simplified for manufacture, then the ease of manufacture is improved, but the ability to control deployment and protect retention members deteriorates
Solution Approach 1:
The device is segmented into modular components (frame, cap, hinge) that can be manufactured separately using standardized processes, then assembled. This segmentation maintains ease of manufacture while enabling sophisticated deployment control through the interaction of discrete components.
Solution Approach 2:
The hinge mechanism utilizes material properties and geometric parameters to enable controlled deployment without complex actuation systems. By carefully selecting hinge geometry and material characteristics, the device achieves reliable deployment control while maintaining manufacturing simplicity.
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 device achieves secure and efficient occlusion of the left atrial appendage with reduced risk of tangling and damage, enabling multiple redeployments and minimizing procedural costs by ensuring consistent and predictable deployment and recapture of the device.
Implementation Method 1
The assembled device has an expanded, deployed configuration and a collapsed, compressed configuration. It is biased into the expanded or deployed configuration by the superelastic nature of the frame material and processing.
Data Source
AI summary
An implantable medical device for insertion in the left atrial appendage includes a cap coupled to a frame. The cap constrains movement of the legs of the frame during collapse and expansion of the device, such that the device can be deployed, recalled and redeployed without the device being damaged or the legs of the frame getting tangled.