Occluder Access Passage and Penetrable Closure for ASD Access
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Solution Overview
Problem
Conventional occluders for atrial septal defects (ASD) prevent subsequent access across the septal wall, making it difficult for medical devices to penetrate and can cause erosion of cardiac tissue.
Innovation Solution
An occluder with an access passage and a penetrable closure that allows for subsequent access and reduces tissue erosion by minimizing radial forces through a flexible frame design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional occluders with continuous metal fabric or wire discs are used to close ASD, then occlusive function is improved, but subsequent access for medical devices is prevented and tissue erosion risk increases
Solution Approach 1:
The occluder disc is segmented into multiple struts rather than using continuous metal fabric or wire. These struts are spaced apart to create inter-strut spaces that allow medical devices to pass through while maintaining occlusive function. The segmentation allows the device to achieve both reliability in closing the defect and ease of subsequent access for medical procedures.
2Reliability
If conventional occluders with continuous metal fabric or wire discs are used, then occlusive function is improved, but tissue erosion risk increases due to radial forces
Solution Approach 1:
The continuous metal fabric or wire is replaced with segmented struts that are spaced apart. This segmentation reduces the radial forces applied to the tissue because the struts distribute the occlusive force over multiple discrete contact points rather than a continuous surface, thereby reducing the risk of tissue erosion while maintaining effective closure of the defect.
Solution Approach 2:
The struts are designed with flexible materials and configurations that allow them to conform to the tissue surface without exerting excessive radial force. The flexible design enables the occluder to maintain occlusive function while minimizing harmful radial forces that could cause tissue erosion.
3Ease of operation
If occluders with access passages are used, then subsequent access for medical devices is enabled, but device complexity increases
Solution Approach 1:
The access passage is created through the natural segmentation of the struts themselves, rather than adding a separate access mechanism. The inter-strut spaces inherently provide the access pathway, eliminating the need for additional complex structures while enabling subsequent medical device access.
Solution Approach 2:
The struts serve multiple functions: they provide structural support for occlusion, create access passages through their spaced configuration, and reduce radial forces through their segmented design. This multi-functionality reduces overall device complexity by combining multiple features into a single structural element.
Data Source
AI summary
The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.