Left Atrial Appendage Closure Device with Shape Memory Wire
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Solution Overview
Problem
Current minimally invasive devices for closing the left atrial appendage are inadequate due to issues with size, stability, and versatility, leading to potential blood clot migration and trauma to the vascular structure, with existing devices either being too large for delivery, insufficiently expandable, or causing damage to the appendage wall.
Innovation Solution
A closure device comprising a containment member that can change configurations from a small delivery size to a larger expanded size, utilizing shape memory wires to secure the device within the appendage, and retaining legs to ensure stability, along with a delivery system for precise placement and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If the device is made collapsible to a small dimension for delivery, then the delivery profile is reduced and minimally invasive procedures are enabled, but the device may lack sufficient stability and sealing capability when expanded
Solution Approach 1:
The device employs a nested configuration where the containment member is collapsed within a delivery catheter during insertion, and only expands to its full operational size after being positioned in the left atrial appendage. This nesting approach enables minimally invasive delivery while ensuring adequate sealing stability when deployed.
Solution Approach 2:
The device utilizes shape memory wires that can dynamically change their configuration from a compressed delivery state to an expanded operational state. The shape memory material enables the containment member to transition between small delivery dimensions and adequate sealing dimensions, resolving the contradiction between delivery profile and sealing stability.
2Reliability
If the device is expanded to a large dimension to ensure adequate sealing, then the sealing capability is improved, but the delivery profile increases and minimally invasive procedures become difficult
Solution Approach 1:
The containment member is designed to be nested within the delivery catheter during insertion, allowing the device to be delivered through small incisions. After positioning, the containment member expands to its full size to provide adequate sealing, thus resolving the contradiction between delivery profile and sealing capability.
Solution Approach 2:
The shape memory wires change their physical parameters (configuration and volume) in response to body temperature or mechanical stimulation, transitioning from a compressed delivery state to an expanded sealing state. This parameter change enables the device to achieve adequate sealing capability while maintaining a small delivery profile.
3Object-affected harmful factors
If the device is made atraumatic to prevent appendage wall perforation, then patient safety is improved, but the device may lack sufficient expansion capability to close off the appendage
Solution Approach 1:
The containment member is constructed from a flexible material that can be compressed to a small delivery profile and then expanded to an adequate size. The flexible construction allows the device to accommodate varying appendage sizes while maintaining atraumatic characteristics, preventing wall perforation while ensuring sufficient expansion capability.
Solution Approach 2:
The shape memory wires provide dynamic expansion capability, allowing the containment member to transition from a compressed delivery state to an expanded operational state. This dynamic behavior enables the device to adapt to different appendage sizes while maintaining atraumatic characteristics throughout the delivery and deployment process.
4Ease of manufacture
If the device is designed with a fixed size, then the manufacturing process is simplified, but the device cannot accommodate varying appendage sizes among patients
Solution Approach 1:
The device employs shape memory wires that enable the containment member to dynamically adjust its size based on the appendage dimensions. This dynamic capability allows a single device design to accommodate varying patient sizes while maintaining manufacturing simplicity, as the size adjustment is achieved through material properties rather than complex manufacturing processes.
Solution Approach 2:
The shape memory material changes its physical parameters (volume and configuration) in response to environmental conditions, enabling the containment member to adapt to different appendage sizes. This parameter change mechanism provides size accommodation while keeping the manufacturing process relatively simple, as the adaptability is built into the material properties rather than requiring complex assembly processes.
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 effectively blocks blood clot migration, maintains secure retention within the appendage, reduces the delivery profile for minimally invasive procedures, and accommodates varying appendage sizes, minimizing the risk of trauma and clot migration while facilitating passage through the vascular system.
Implementation Method 1
A closure device for closing a left atrial appendage of a patient comprises a containment member having a first configuration for passage into the left atrial appendage and a second larger configuration, a wire movable into the containment member in situ to expand the containment member in the atrial appendage to the second configuration
Data Source
AI summary
A device for closing a left atrial appendage of a patient comprising a containment member having a first configuration for passage into the left atrial appendage and a second larger configuration, and a wire movable into the containment member in situ to expand the containment member in the left atrial appendage to the second configuration.