Biocompatible Graft With Capping Member For Fistula Sealing
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Solution Overview
Problem
Current medical products for treating fistulae, particularly gastrointestinal fistulae, lack effective solutions for sealing and closing fistulae, often resulting in complications such as infection flare-ups and prolonged healing times due to the complexity and variability of fistula paths.
Innovation Solution
A biocompatible medical graft product with a capping member and an elongate plug member, formed from remodelable materials like submucosa, is designed to block the primary fistula opening and extend into the fistula tract, using expandable elements and anchoring adaptations to ensure secure placement and promote tissue ingrowth for healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If sealant or sclerosant is injected into an unprepared or infected fistula, then the procedure can be completed in one stage, but this may cause a flare-up of infection and even further abscess formation
Solution Approach 1:
The patent applies preliminary action by placing a seton (drainage device) in the fistula tract before injecting sealant or sclerosant. This preliminary seton placement allows residual infection to resolve and the fistula tract to mature, creating safe conditions for the subsequent sealant injection without causing infection flare-ups
Solution Approach 2:
The patent uses an intermediary approach by introducing a biocompatible graft product that includes both a capping member and plug member. This graft product serves as a mediator that can be implanted to promote tissue ingrowth and closure while preventing infection, replacing the need for separate seton placement and sealant injection stages
2Reliability
If a fistula graft product is implanted to seal the fistula opening, then healing is facilitated, but the complexity of the fistula path and variability make effective sealing difficult
Solution Approach 1:
The patent applies segmentation by dividing the graft product into two distinct members: a capping member configured to contact the alimentary canal wall adjacent to the primary opening, and a plug member configured to extend into the fistula tract. This segmented design allows each component to address specific aspects of the fistula anatomy, improving sealing effectiveness while adapting to complex and variable fistula paths
Solution Approach 2:
The patent applies local quality by designing the capping member and plug member with different configurations and properties suited to their specific locations and functions. The capping member is designed to seal the primary opening area, while the plug member is designed to fill and seal the tract, allowing each part to have optimized properties for its local requirements
Data Source
Figure 1A~1E
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Figure 3A~3B
AI summary
Described are medical graft products, systems, and methods useful for treating fistulae, particularly enterocutaneous fistulae. Certain products of the invention are configured to have portions residing in and around a primary fistula opening in a wall of the alimentary canal. One such product includes a biocompatible graft body which is configured to block at least the primary opening. The graft body includes a capping member connected to an elongate plug member. The capping member is configured to contact portions of the alimentary canal wall adjacent to the primary opening, and the elongate plug member is configured to extend into at least a portion of the fistula. A graft product of this sort may be particularly adapted to allow a portion of the capping member to be positioned alongside an exterior, lateral surface of the plug member, e.g., when placed in a delivery device lumen. Such a capping member may be hingedly or non-hingedly coupled to the elongate plug member.