Interseptal Occluder Diaphragm for Re-Crossable Defect Closure
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Solution Overview
Problem
Existing occluder devices for closing defects in heart partitions, such as atrial and ventricular septal defects, do not allow for easy re-crossing after implantation, are complex to implement, and fail to provide flexible occlusion while allowing for variable crossing points.
Innovation Solution
A crossable interseptal occluder device with a support structure and a diaphragm featuring elongated occluding bridges that expand to occlude the defect, allowing medical instruments to pass through while maintaining occlusion, and is made of elastic materials for flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a conventional occluder device is used to close a partition defect, then the defect is occluded, but the device does not allow re-crossing through the partition
Solution Approach 1:
The occluder device is divided into separate components: a first element with a first disc and first anchoring element, and a second element with a second disc and second anchoring element. This segmentation allows the device to be delivered in a compressed state through catheterization and then expanded at the defect site, providing both reliable occlusion and the ability to cross the partition during delivery and potential re-crossing procedures.
Solution Approach 2:
The device transitions from a compressed delivery configuration to an expanded deployed configuration. The anchoring elements are configured to engage the partition in the expanded state, providing secure occlusion. The dynamic transition allows the device to be delivered percutaneously while maintaining the ability to cross the partition during the procedure and potentially allows for re-crossing in future procedures.
2Reliability
If a clip-based occluder device is used, then the partition defect is closed, but the device structure becomes complex and does not allow re-crossing
Solution Approach 1:
The device is segmented into two main elements that can be delivered separately or as a unit. Each element has a disc and anchoring component, simplifying the overall structure compared to complex clip mechanisms. The segmented design allows for easier delivery through catheterization and deployment at the defect site without requiring complex mechanical structures.
Solution Approach 2:
The discs of the occluder device are made of flexible material that can be compressed for delivery and then expanded at the target site. This flexibility eliminates the need for complex mechanical expansion mechanisms while providing reliable occlusion when expanded. The flexible nature of the discs also allows them to conform to the partition defect, ensuring effective closure.
3Reliability
If an occluder device is implanted to close a partition defect, then the defect is occluded, but the crossing point cannot be varied for different surgical approaches
Solution Approach 1:
The occluder device is designed to be delivered percutaneously through venous access and can be positioned at various partition defects including atrial septal defects and ventricular septal defects. The device's universal design allows it to accommodate different defect locations and sizes, and the delivery system can access the heart through standard femoral vein approach, providing versatility for different surgical scenarios while maintaining reliable occlusion.
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 provides reliable occlusion of heart partition defects while enabling re-crossing, simplifying implementation, and adapting to different surgical approaches by allowing flexible crossing points.
Implementation Method 1
said support structure being configured to expand and contract between a compressed tubular configuration for the insertion through the patient's vasculature and an expanded or extended configuration in which the first and second anchoring portions extend radially outwards
Implementation Method 2
said diaphragm being supported by said support structure and arranged to close the majority of said lumen when said diaphragm is in a relaxed configuration
Data Source
Figure 1
Figure 2~3
Figure 4A~5
AI summary
The present invention relates to a crossable interseptal occluder device (1) comprising: - a support structure (2); wherein - said support structure (2) comprises a central support structure portion (3) which delimits a lumen (4); - said support structure (2) comprises a first anchoring portion (5) and an opposite second anchoring portion (6); - said support structure (2) being configured to expand and contract between a compressed tubular configuration for the insertion through the patient's vasculature and an expanded or extended configuration in which the first and second anchoring portions (5, 6) extend radially outwards from said central support structure portion (3) to compress a partition (7) therebetween by arranging said support structure (2) astride said partition (7) through a defect or hole or opening present in the partition (7); and wherein - said crossable interseptal occluder device (1) further comprises at least one diaphragm (8); - said diaphragm (8) being supported by said support structure (2) and arranged to close the majority of said lumen (4), when said diaphragm (8) is in a relaxed configuration with the supporting structure (2) being extended; - said diaphragm (8) being configured to allow a medical instrument inserted into a first compartment (9 or 10) delimited by said partition (7) to pass through the diaphragm (8) and then through said lumen (4) entering a second compartment (10 or 9) delimited by said partition (7); wherein - said diaphragm (8) comprises a plurality of elongated membrane occluding fringes or bridges (21) or occluding bridges (21); - each of said occluding bridges (21) comprises an elongated body (50) having opposite elongated body ends or ends (51, 52) and opposite longitudinal edges or sides (22); - in a relaxed configuration of said diaphragm (8), each occluding bridge (21) of said plurality of occluding bridges (21) is arranged close to at least a further occluding bridge (21) of said plurality of occluding bridges (21); - at least one portion of said longitudinal sides (22) of each occluding bridge (21) and at least one portion of said longitudinal sides (22) of said at least a further occluding bridge (21) delimit at least one slit or one cut (27) into said diaphragm (8); - both said opposite ends (51, 52) of each occluding bridge (21) are directly or indirectly connected to or supported by said support structure (2).