Segmented Occluder Frame for GI Tract Defect Sealing
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Solution Overview
Problem
Current medical devices lack effective solutions for sealing defects in the gastrointestinal tract, particularly large resections, due to the hostile environment and challenges in developing tools that can adequately seal and prevent lumen stricture.
Innovation Solution
The development of implantable medical devices with a frame having a single elongate member, including a supporting portion, an occluding portion, and a defect-occupying portion, along with a sealing material attached to the occluding portion to inhibit material flow through the aperture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If clips or sutures are used to seal the perforation in the colon wall, then the defect can be sealed, but lumen stricture occurs due to approximation of defect edges
Solution Approach 1:
The device is divided into three distinct portions: a supporting portion that contacts the outer tissue surface, an occluding portion that seals the aperture from the inner lumen, and a defect-occupying portion that bridges the defect. This segmentation allows sealing without approximating defect edges, avoiding lumen stricture while maintaining sealing effectiveness.
Solution Approach 2:
The defect-occupying portion acts as an intermediary element that spans the aperture without requiring approximation of the defect edges. This mediator structure allows the supporting and occluding portions to seal the defect from opposite sides while maintaining lumen patency.
2Reliability
If the device provides apposition force against tissue around the aperture, then sealing is improved, but the device may cause tissue damage or stricture
Solution Approach 1:
The device applies apposition force locally at the supporting portion and occluding portion that contact healthy tissue, while the defect-occupying portion specifically targets the aperture area without applying force to surrounding tissue. This localized force distribution achieves sealing while minimizing tissue damage.
3Device complexity
If a single elongate member is used to form the frame, then device complexity is reduced, but manufacturing precision must be maintained
Solution Approach 1:
The frame is formed from a single elongate member that is bent and shaped to create the supporting portion, occluding portion, and defect-occupying portion. This merging of multiple functional elements into one continuous structure reduces device complexity and the number of assembly steps while requiring precise forming during manufacturing.
Data Source
AI summary
An implantable medical device for sealing and repairing defects in a body tissue or for creating an anastomosis includes a frame and a covering material. In some embodiments, the frame includes a single continuously wound wire that defines an apposition portion, a defect-occupying portion, and a sealing portion. In some embodiments, the tissue-sealing and anastomosis devices provided herein are well-suited for use in the GI tract including the small bowel and colon. In some embodiments, a two-part frame construct facilitates independent tailoring of apposition forces and radial forces exerted on tissues by the two-part frame.