Atrial Appendage Occlusion Device with Conformable Membrane
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Solution Overview
Problem
Current implantable medical devices for occluding cardiac structures, such as atrial appendages, face challenges in achieving complete and rapid closure, reducing thrombus formation, and ensuring patient safety due to non-uniform surfaces that disrupt blood flow and lead to embolic strokes.
Innovation Solution
The development of implantable occlusive devices with a unitary self-expanding frame and nitinol cut-tube frames that include a membrane, designed to conform to the atrial appendage walls, providing a uniform surface for enhanced sealing and reduced thrombus formation, and are deployable via transcatheter techniques.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a conventional occlusion device is deployed in the atrial appendage, then occlusion of the appendage is achieved, but the device creates a non-uniform surface that disrupts blood flow and leads to thrombus formation
Solution Approach 1:
The patent employs a flexible membrane that conforms to the irregular geometry of the atrial appendage ostium. This membrane creates a uniform occlusive surface that prevents blood flow disruption and thrombus formation while adapting to the anatomical variations of the patient's anatomy.
Solution Approach 2:
The device incorporates a frame with varying structural characteristics - rigid portions for structural support and flexible portions for conforming to the appendage geometry. This local differentiation allows the device to maintain both structural integrity and surface uniformity for thrombus prevention.
2Reliability
If the occlusion device is made more complex to achieve complete closure, then sealing improvement is achieved, but device complexity and difficulty of deployment increase
Solution Approach 1:
The patent integrates the frame, membrane, and delivery system components into a cohesive unit that achieves complete closure through a streamlined design. The frame and membrane work as a unified structure, eliminating the need for separate deployment steps and reducing overall device complexity.
Solution Approach 2:
The device utilizes self-expanding frame mechanics that automatically achieve proper positioning and sealing upon deployment. This self-adjusting mechanism ensures complete closure without requiring complex actuation systems or multiple deployment steps.
3Productivity
If the device is designed for rapid deployment, then procedural time is reduced, but sealing completeness may be compromised
Solution Approach 1:
The device is pre-configured in a compressed state within the delivery system, with the membrane and frame pre-positioned for immediate deployment. This preliminary arrangement allows for rapid insertion while ensuring that the sealing surfaces are already aligned for complete closure upon deployment.
Solution Approach 2:
The device incorporates dynamic elements that allow rapid expansion and adaptation to the appendage geometry during deployment. The flexible membrane and self-expanding frame work together to achieve both speed and sealing completeness through controlled mechanical transformation.
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 devices achieve improved sealing, reduced thrombus formation, and enhanced clinical outcomes by conforming to the atrial appendage walls, preventing blood stagnation and embolic strokes, while being easier to use and safer for patients.
Implementation Method 1
a unitary self-expanding frame having a proximal end, a distal end, and a longitudinal axis
Implementation Method 2
a nitinol cut-tube frame having a proximal end and a distal end
Implementation Method 3
the plurality of elongate members may be configured to bend or flex substantially in a plane orthogonal to the longitudinal axis and mitigate longitudinal movement of the face portion in response to a compressive force applied to the body portion
Data Source
AI summary
Various aspects of the present disclosure are directed toward apparatuses, methods, and systems as relating to occlusion. In certain instances, the apparatuses, methods, and systems may include a device for placement in vessels, appendages, and openings in a body. The device may include a unitary frame having a face portion that includes a center frame portion a plurality of elongate members.