Foldable Fabric Occluder for Atrial Septal Defect Closure
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Solution Overview
Problem
Conventional occluding devices for atrial septal defects (ASDs) pose challenges such as limited future surgical access, interference with magnetic imaging techniques, nickel allergy risks, and disruption to the heart's conduction system due to metallic frames, and often result in erosion or disruption of the implanted heart tissue.
Innovation Solution
A medical device with foldable occluding members and an elongate shaft extending between them, allowing for expansion and contraction to treat ASDs while minimizing metallic material, facilitating deployment via a delivery system that includes a catheter and cable for precise positioning and deployment at the target site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If metallic frame devices are used for occluding ASDs, then structural strength and occlusion effectiveness are improved, but future surgical access is limited and magnetic imaging is interfered with
Solution Approach 1:
The patent removes the metallic frame component entirely from the occluding device, extracting only the essential function of occlusion through alternative means (fabric members and cord). This eliminates the harmful effects of metal on future surgical access and magnetic imaging while maintaining the primary function of closing the ASD.
Solution Approach 2:
The patent employs flexible fabric members instead of rigid metallic frames to achieve occlusion. These fabric members can be delivered through catheters and deployed within the heart, providing both the necessary structural function and biocompatibility without the drawbacks of metallic materials.
2Reliability
If metallic frame devices are used for occluding ASDs, then occlusion effectiveness is improved, but nickel allergy risks and conduction system disruption occur
Solution Approach 1:
The patent extracts and eliminates the metallic frame component that causes nickel allergy and conduction system disruption, replacing it with non-metallic fabric members that provide occlusion effectiveness without the associated harmful effects.
Solution Approach 2:
The patent uses fabric members made from biocompatible materials that combine the necessary mechanical properties for occlusion with biological compatibility, avoiding the adverse reactions associated with metallic materials while maintaining structural integrity.
3Reliability
If conventional occluding devices are used, then ASD occlusion is achieved, but device complexity and surgical access difficulty increase
Solution Approach 1:
The occluding device is divided into separate components (first fabric member, second fabric member, cord) that can be independently delivered and assembled at the target site. This segmentation allows for simpler delivery through catheters and easier deployment while achieving reliable occlusion.
Solution Approach 2:
The device employs dynamic elements including the foldable fabric members that can transition from a compressed delivery state to an expanded occlusion state, and the movable cord that enables adjustment and securing of the fabric members during deployment.
Data Source
AI summary
A medical device for treating an atrial septal defect (ASD) includes a first occluding member, and a second occluding member disposed in opposition to the first occluding member. The medical device also includes at least one elongate shaft extending through and between the first occluding member and the second occluding member. The first occluding member is foldable to expand and contract relative to the second occluding member. The second occluding member is foldable to expand and contract relative to the first occluding member. In operation, at least one of the first occluding member and the second occluding member is configured to expand relative to the other of the first occluding member and the second occluding member to treat the ASD at the target site.