Dual Securement Occluder Delivery System
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Solution Overview
Problem
Current septal closure devices for atrial septal defects and patent foramen ovale (PFO) are technically complex, prone to complications such as thrombus formation, conduction system disturbances, and residual leaks, and lack anatomical conformability, leading to unfavorable body adaptation and inconsistent performance.
Innovation Solution
A delivery system for a septal occluder with a tubular structure made from materials like metals, shape memory alloys, or polymers, featuring a catch system that maintains the axial length and includes loops for compressive force on septal tissue, secured by securement systems like threaded connections and collet systems, allowing for controlled deployment and retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single securement system is used to attach the occluder to the delivery system, then the device structure is simpler, but the occluder may rotate or detach during deployment, compromising delivery reliability
Solution Approach 1:
The securement system is divided into two independent attachment points: a proximal securement system at one end of the occluder and a distal securement system at the other end. This segmentation prevents rotation and detachment by securing both ends separately, thereby improving reliability without excessive complexity
Solution Approach 2:
The occluder is pre-configured with complementary geometric features (e.g., protrusions and recesses, or threaded connections) that enable secure engagement with the delivery system before deployment. This preliminary configuration ensures reliable attachment is established prior to the critical deployment phase
2Reliability
If the occluder is made from large masses of material to ensure occlusion, then the occlusion effectiveness is improved, but the device profile increases and body adaptation becomes unfavorable
Solution Approach 1:
The occluder is segmented into two functional sides (proximal and distal) that can be optimized independently. Each side can be sized and shaped to provide effective occlusion while maintaining a compact overall profile suitable for percutaneous delivery
Solution Approach 2:
The occluder employs thin, flexible disc-shaped structures that can conform to the septal anatomy. These thin-film constructions provide effective occlusion without the bulk of large masses of material, thereby maintaining a favorable device profile
3Device complexity
If the occluder is deployed without a catch system to simplify the device, then the device complexity is reduced, but the occluder cannot maintain its compressed configuration during delivery
Solution Approach 1:
The catch system is extracted as a separate, dedicated component rather than being integrated into the occluder structure itself. This allows the occluder to maintain its simple design while the catch system provides the necessary function of maintaining compressed configuration during delivery
Solution Approach 2:
The catch system acts as an intermediary mechanism between the occluder and the delivery system. It temporarily holds the occluder in its compressed state during delivery and then releases it at the deployment site, enabling stable delivery without complicating the occluder's own structure
4Ease of operation
If ASD closure devices are used for PFO closure, then the device can be deployed percutaneously, but the device lacks anatomical conformability to the flap-like PFO anatomy
Solution Approach 1:
The occluder is designed with different characteristics on its proximal and distal sides to match the specific anatomical requirements of PFO closure. Each side can be optimized for local anatomical conditions while maintaining overall percutaneous deployability
Solution Approach 2:
The occluder employs dynamic, flexible structures that can adapt to the flap-like PFO anatomy after deployment. The device transitions from a compressed delivery state to an expanded deployed state where it conforms to the irregular PFO geometry, combining ease of percutaneous delivery with anatomical adaptability
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. Specifically, a petal-shaped occluder with a catch system is provided within a delivery sheath. In certain embodiments, the delivery system includes a first securement system for securing a first end of the occluder and a second securement system for securing a second end of the occluder to a delivery catheter and a delivery wire contained in the delivery system. The securement enable the deployment (and retrieval) of the device. The securement systems enable pushing and pulling of respective ends of the occluder to expand and contract the device by varying its axial length. In one aspect, the first securement system employs a threaded connection and the second securement system employs a suture connection. In another aspect, the first securement system employs a threaded connection and the second securement system employs a collet finger connection. The securement systems are detached when the device has been properly positioned. The securement systems can be manipulated by control systems provided in the control portion of the delivery system.