GI Tissue Occluder Frame for Sealing Defects Without Stricture
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Solution Overview
Problem
Existing medical devices lack the ability to effectively seal large defects in the gastrointestinal tract without approximating defect edges, particularly in dynamic environments like the colon, due to the lack of suitable tools and devices that can withstand peristaltic movements and fecal matter.
Innovation Solution
The development of implantable medical devices with a frame comprising a single elongate member that conforms to tissue surfaces, providing apposition forces and includes a sealing material to inhibit material flow through the defect, and a defect-occupying portion that does not provide substantial apposition force, allowing for secure sealing and healing of tissue defects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If clips or sutures are used to seal the defect, then the defect can be sealed, but lumen stricture occurs due to approximation of defect edges
Solution Approach 1:
The device applies different functional properties to different regions: the first and second apposition members provide sealing force at the defect margins, while the defect-occupying portion explicitly avoids providing substantial apposition force to the tissue around the aperture, preventing stricture while maintaining seal integrity
Solution Approach 2:
The device is divided into functionally distinct segments: supporting portion (first apposition member), defect-occupying portion, and occluding portion (second apposition member), each performing a specific function to resolve the contradiction between sealing and preventing stricture
2Force
If a rigid sealing device is used to seal the defect, then sealing force can be provided, but the device cannot withstand peristaltic movements in the colon
Solution Approach 1:
The device transitions from a static rigid structure to a dynamic flexible structure that can adapt its shape and provide continuous sealing force while accommodating peristaltic movements and maintaining apposition to the irregular tissue surfaces in the dynamic colon environment
Solution Approach 2:
The device employs flexible apposition members that can conform to tissue surfaces and adapt to dynamic movements, providing sustained sealing force without rigid structural constraints
3Reliability
If a device provides uniform apposition force across the entire defect area, then sealing is improved, but migration and fixation issues occur in dynamic anatomies
Solution Approach 1:
The device creates localized zones of high apposition force at the defect margins where sealing is needed, while the defect-occupying portion provides minimal force to avoid tissue distortion, achieving stable fixation without uniform force distribution
Solution Approach 2:
The segmented structure allows independent optimization of each portion: the supporting and occluding portions provide anchoring and sealing forces for stability, while the defect-occupying portion remains compliant to prevent migration
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.