PFO Occluder Catch System Locking Cap Radial Force
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Solution Overview
Problem
Current septal closure devices for conditions like patent foramen ovale (PFO) are technically complex, prone to complications such as thrombus formation, arrhythmia, and residual leaks, and lack anatomical conformability, leading to insecure deployment and potential hemodynamic disturbances.
Innovation Solution
A septal occluder device with a catch system, including a locking funnel cap and catch member, that secures the occluder in a deployed configuration using a delivery system, ensuring proper seating and reducing the risk of complications by applying radial force to maintain the occluder's position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If umbrella devices and mechanical closure devices are used to close PFO, then patients can avoid the side effects of anticoagulation therapies and the risks of invasive surgery, but the devices are not optimally suited for use as PFO closure devices, leading to complications such as thrombus formation, fractures of components, conduction system disturbances, perforations of heart tissue, arrhythmia and residual leaks
Solution Approach 1:
The device incorporates a catch system with a catch member and locking cap specifically designed for PFO anatomy. The catch member includes a catch surface that engages with the septal tissue and a locking mechanism that secures the occluder in place, providing localized structural support and stability tailored to the PFO closure requirement, thereby reducing complications while maintaining reliability
Solution Approach 2:
The device is pre-formed with a compressed configuration that allows delivery through a catheter, and upon release, automatically expands to the deployed configuration. The catch system is pre-positioned within the occluder structure, ready to engage and secure the device in place immediately upon deployment, ensuring reliable closure from the outset
2Reliability
If ASD devices are designed to occlude holes, then they can close septal defects, but they lack anatomic conformability to the flap-like anatomy of PFOs, leading to insecure deployment and potential hemodynamic disturbances
Solution Approach 1:
The occluder is designed with a catch system that provides localized structural support at critical points. The catch member with its catch surface and the locking cap create a secure engagement point that adapts to the flap-like PFO anatomy, ensuring the device conforms properly to the local tissue geometry while maintaining deployment security
Solution Approach 2:
The device transitions from a compressed delivery configuration to a deployed configuration where the occluder expands and the catch system engages. This dynamic transformation allows the device to adapt to the PFO anatomy, providing secure deployment while maintaining conformability to the flap-like structure
3Ease of operation
If the occluder is delivered in a compressed configuration and then expanded, then it can be delivered through a catheter, but a catch system is required to maintain the deployed configuration, adding complexity to the device
Solution Approach 1:
The catch system is nested within the occluder structure itself. The catch member is positioned inside the occluder body, and the locking cap threads onto the occluder, creating a compact integrated system that maintains deployed configuration without adding external complexity, thus preserving delivery ease while providing necessary security
4Stability of the object's composition
If the catch system applies radial force to secure the occluder, then it maintains the deployed configuration, but the locking mechanism must be strong enough to prevent dislodgement while allowing controlled deployment
Solution Approach 1:
The catch system is designed with a locking cap that threads onto the occluder in a controlled manner during deployment. The threading action gradually engages the locking mechanism, building strength progressively while maintaining controlled deployment. Once engaged, the locking cap provides sufficient radial force to prevent dislodgement while allowing the deployment process to complete smoothly
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 solution effectively secures the occluder in place, reducing the risk of complications and ensuring a stable, anatomically conformable closure, thereby minimizing thrombus formation and hemodynamic disturbances.
Implementation Method 1
The locking funnel cap applies a radial force on the proximal end of the occluder to secure the catch member proximal to the occluder
Data Source
AI summary
Devices, delivery systems and delivery techniques for an occlusion device for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. The devices, delivery systems and delivery techniques relate particularly to, but are not limited to, a patent foramen ovale (PFO) occluder made from a polymer tube. In certain embodiments, the occluder includes a catch system that holds the occluder in the deployed, expanded profile. The catch system includes a locking funnel cap. In some embodiments, the locking funnel cap forces the proximal ends of the occluder in a radially inward position to lock the catch member in place and prevent the occluder from moving from its deployed configuration.