Occluder Frame Segmentation for Sealing Large GI Tissue Defects
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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 environments with peristaltic movements and fecal matter, making endoscopic procedures challenging.
Innovation Solution
Implantable medical devices with a frame or wire member that includes a supporting portion, an occluding portion, and a defect-occupying portion, featuring a sealing material to inhibit material flow through the aperture, and a self-expanding mechanism for secure tissue apposition.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If clips or sutures are used to approximate defect edges for sealing, then the defect can be sealed, but lumen stricture occurs
Solution Approach 1:
The device is divided into three distinct functional segments: a supporting portion that contacts the outer tissue surface, an occluding portion with sealing material 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.
2Ease of operation
If endoscopic procedures are performed in the colon environment, then minimally invasive treatment is achieved, but peristaltic movements and fecal matter interfere with sealing
Solution Approach 1:
The occluding portion incorporates a flexible sealing material that can conform to the dynamic colon environment. This flexible membrane provides a durable seal that accommodates peristaltic movements while preventing fecal matter leakage, enabling endoscopic procedures in the challenging colon environment.
Solution Approach 2:
The device features a curved or contoured sealing surface that conforms to the cylindrical geometry of the colon wall. This curvature allows the sealing material to maintain contact with the tissue surface during peristalsis, ensuring continuous sealing effectiveness despite intestinal movements.
3Reliability
If large resections are performed to remove invasive lesions, then complete lesion removal is achieved, but sealing the resulting perforation becomes challenging
Solution Approach 1:
The device combines multiple functions in a single implantable structure: it provides structural support to the defect area, occludes the aperture to prevent leakage, and creates an anastomosis to restore intestinal continuity. This multi-functionality simplifies the overall treatment approach for large resections while ensuring reliable sealing.
4Device complexity
If a single continuous wire is used for the frame, then device simplicity is improved, but sufficient apposition force against tissue surfaces is difficult to achieve
Solution Approach 1:
The single continuous wire frame is designed with varying local properties: the supporting portion has a configuration optimized for contacting the outer tissue surface, the occluding portion incorporates sealing material for aperture sealing, and the defect-occupying portion bridges the defect. This local differentiation allows the simple single-wire structure to generate sufficient apposition force at each interface.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Provides a durable seal in dynamic anatomical environments, facilitating healing by preventing leakage and allowing for endoscopic procedures in challenging conditions.
Implementation Method 1
a self-expanding mechanism for secure tissue apposition
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.