Deformable Flap Catch for Occluder Deployment
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Solution Overview
Problem
Current septal closure devices for conditions like atrial septal defects and patent foramen ovale (PFO) face challenges such as complex implantation procedures, thrombus formation, conduction system disturbances, and anatomical non-conformity, leading to residual leaks and inconsistent performance.
Innovation Solution
A collapsible medical device with a catch system featuring a flap at its proximal end, which secures the device in a deployed configuration by fitting within the occluder's inner lumen, allowing for secure deployment and retrieval, and is designed to maintain an expanded profile for effective occlusion while minimizing thrombus formation risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a catch system with a deformable flap is used to secure the occluder in deployed configuration, then device stability and secure deployment are improved, but device complexity increases
Solution Approach 1:
The flap is designed to be deformable rather than rigid, allowing it to dynamically change shape during deployment. The flap deforms to allow passage of the occluder and then returns to its original configuration to engage with the occluder, providing automatic securing without complex mechanical components
Solution Approach 2:
The deformable flap utilizes the elastic recovery properties of the material to automatically return to its engagement position after deforming during deployment. This self-service mechanism eliminates the need for additional actuators or complex locking mechanisms, achieving reliable securing through the material's inherent elastic properties
2Ease of operation
If the occluder is designed with an axial passage for the catch member, then ease of deployment and retrieval are improved, but thrombus formation risk increases due to potential hemodynamic disturbances
Solution Approach 1:
The occluder is designed with a thin-walled tubular structure that is flexible yet maintains structural integrity. This thin-walled design minimizes the cross-sectional area and reduces hemodynamic disturbances compared to bulky structures, thereby lowering thrombus formation risk while still providing the necessary axial passage for the catch member
Solution Approach 2:
The occluder features a smooth, curved tubular geometry that promotes laminar flow and minimizes turbulence. The curved surfaces and streamlined shape reduce flow separation and vortex formation, decreasing the risk of thrombus generation while maintaining the axial passage functionality
3Reliability
If the device maintains an expanded profile for effective occlusion, then occlusion effectiveness is improved, but device adaptability to narrow PFO openings deteriorates
Solution Approach 1:
The occluder is designed with dynamic shape-changing capabilities through its thin-walled tubular structure that can compress to a narrow profile for delivery through small PFO openings and then expand to an effective occluding profile once deployed. This dynamic transformation allows the device to adapt to varying anatomical dimensions
Solution Approach 2:
The occluder structure incorporates segmented or expandable elements within the tubular design that allow progressive expansion from a compressed delivery state to a fully expanded occlusion state. This segmentation enables the device to navigate narrow openings while achieving effective occlusion dimensions
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 ensures secure and consistent deployment with reduced thrombus formation risks, improving anatomical conformability and reducing complications associated with existing septal closure devices.
Implementation Method 1
a deformable flap that is able to move in an axial direction relative to a proximal end of the occluder portion
Data Source
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AI summary
Devices, delivery systems, and delivery techniques for an occlusion device for closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. Specifically, an occluder with a catch member (50) that holds the occluder in the deployed, expanded profile configuration is provided within a delivery sheath. The proximal end of the catch member (50) includes a flap (98) that when positioned proximal to the proximal end of the occluder holds the occluder in the expanded profile configuration. The flap (98) is sized and formed of a material that allows the flap (98) to deform by bending back and forth in axial and radial directions. In certain embodiments, the flap (98) has segments (102, 104) divided by notches. In certain embodiments, deforming the flap (98) in the proximal direction requires a different amount of force than deforming the flap (98) in the distal direction.