Fistula Graft with Capping Member and Plug for Sealing
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Solution Overview
Problem
Current methods for treating fistulae often result in complications such as incontinence and impaired sphincter control, and existing treatments for gastrointestinal fistulae are inadequate, with limited effectiveness in sealing off fistula openings and promoting healing.
Innovation Solution
A medical graft product comprising a biocompatible graft body with a capping member and an elongate plug member, configured to block the primary fistula opening and extend into the fistula tract, using remodelable materials like submucosa to promote tissue ingrowth and healing, and incorporating anchoring adaptations for secure placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical fistulotomy is performed to treat fistulae, then the fistula tract is cleared and healing is promoted, but sphincter muscle is divided causing incontinence and impaired sphincter control
Solution Approach 1:
The fistula treatment is divided into two distinct stages: first placing a seton to isolate and drain the fistula tract, then later injecting sealant or sclerosant to close the tract. This segmentation allows the sphincter to be preserved during the first stage while achieving closure in the second stage, avoiding the incontinence problem caused by immediate surgical division.
Solution Approach 2:
The seton is placed in advance to establish drainage and isolate the fistula tract from surrounding tissues before the definitive closure procedure. This preliminary action prepares the tract for subsequent sealant injection while maintaining sphincter integrity, preventing the harmful effect of premature sphincter division.
2Reliability
If sealant or sclerosant is injected into an unprepared infected fistula, then fistula closure is achieved, but infection flares up and abscess formation increases
Solution Approach 1:
The seton is placed in advance to drain the infected fistula tract and allow inflammation to subside before sealant injection. This preliminary drainage action reduces the bacterial load and prepares the tract for safe closure, preventing infection flare-up when the sealant is later injected.
Solution Approach 2:
The seton acts as a protective measure by establishing continuous drainage and isolating the infected tract from surrounding healthy tissues before the closure procedure. This beforehand cushioning prevents the harmful effect of infection flare-up that would occur if sealant were injected directly into an active infection.
3Ease of operation
If spontaneous closure of fistulae is awaited, then non-surgical treatment is provided, but closure occurs in less than 30% of cases requiring prolonged preparation time
Solution Approach 1:
The seton serves as an intermediary device that facilitates the closure process by draining the fistula tract and preparing it for eventual closure. This intermediary action increases the closure rate from less than 30% to a much higher success rate, while still maintaining a relatively non-surgical approach compared to immediate fistulotomy.
Data Source
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.