Occlusion Device with Segmented Nitinol Frame
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Solution Overview
Problem
Existing occlusion devices for bodily passages face limitations due to bulkiness, reliance on thrombosis for occlusion, and reduced effectiveness in patients with clotting disorders, such as those undergoing anti-coagulant therapy.
Innovation Solution
The development of occlusion devices featuring a disc-shaped support frame with a crossbar and a covering, designed to provide a mechanical blockage without relying on thrombosis, utilizing a flexible disc-shaped member and crossbar structure made from biocompatible materials like Nitinol and cobalt chromium, with a covering that ensures continuous contact to block fluid flow effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex multi-filament frame structures are used to achieve occlusion, then occlusion effectiveness is improved, but device bulk and profile increase limiting use to larger passages
Solution Approach 1:
The frame structure is divided into multiple discrete elements (first frame element, second frame element, third frame element) that are interconnected. This segmentation allows each element to be optimized independently for strength while reducing overall material usage and device bulk compared to a solid multi-filament structure.
Solution Approach 2:
The frame elements are constructed as thin-walled tubular structures rather than solid multi-filament bundles. This thin-film approach maintains structural integrity and occlusion effectiveness while significantly reducing device bulk and profile, enabling deployment in smaller bodily passages.
2Reliability
If thrombosis-based occlusion mechanism is used, then occlusion is achieved, but effectiveness is reduced in patients with clotting disorders and thrombus may be reabsorbed over time
Solution Approach 1:
The invention replaces the biochemical thrombosis-based occlusion mechanism with a purely mechanical blockage system. The frame structure physically obstructs fluid flow through its geometric configuration, providing reliable occlusion that is independent of the patient's clotting ability and not subject to thrombus reabsorption.
3Volume of moving object
If reduced device bulk is achieved for easier delivery, then deliverability to smaller vessels is improved, but structural strength may be compromised
Solution Approach 1:
The frame elements are constructed from elastic memory materials (such as Nitinol) that provide exceptional strength-to-weight ratio. This composite approach combines the flexibility and low bulk of thin-walled structures with the high structural strength of shape memory alloys, enabling small device profile without compromising occlusion effectiveness.
Solution Approach 2:
The frame elements utilize elastic memory properties to dynamically adapt their configuration. During delivery, the compressed low-bulk configuration is maintained, and upon deployment, the elastic memory effect restores the frame to its high-strength occlusive configuration, providing both reduced bulk and maintained strength.
Data Source
AI summary
An occlusion device has a covering attached to a support frame that includes a disc-shaped member and a crossbar that extends across a central opening defined by the disc-shaped member. The occlusion device has a first, or deployed, configuration in which the crossbar defines a curve that extends from the disc-shaped member, and a second, or resting, configuration in which the discshaped member and the crossbar lie substantially in a single plane. Each of the disc-shaped member and the crossbar include a core wire that extends through a lumen of a coil multiple times.