Perianal Fistula Coil Occlusion With Drainage Seton Anchoring
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Solution Overview
Problem
Current treatments for perianal fistulas, such as fistulotomy and use of setons or plugs, often result in faecal incontinence or fail to effectively heal the fistula, with existing glues and plugs having low success rates and high reinfection risks.
Innovation Solution
A perianal fistula treatment device featuring a tapered coil with anchoring and sealing mechanisms that occludes the internal opening, preserves sphincteric function, and facilitates drainage, using bioabsorbable materials to ensure effective healing and prevent reinfection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fistulotomy procedure is performed to cure the fistula tract, then the cure rate is improved, but the risk of faecal incontinence increases
Solution Approach 1:
The fistula treatment device segments the treatment approach by separating the occlusion function (plug) from the anchoring function (seton with barbs). The plug is delivered through the seton, allowing the seton to secure the device while maintaining drainage capability, thus achieving high cure rate without compromising continence
Solution Approach 2:
The plug is nested within the seton structure, with the plug being delivered through the lumen of the seton. This nested configuration allows the smaller plug to be positioned precisely at the fistula tract while the larger seton provides external support and drainage pathway, resolving the contradiction between secure anchoring and continence preservation
2Object-affected harmful factors
If seton is used as sphincter sparing technique to preserve continence, then the risk of faecal incontinence is reduced, but the effectiveness of fistula cure is insufficient
Solution Approach 1:
The invention merges two traditional techniques (seton and plug) into a single integrated device. The seton provides sphincter-sparing anchoring and drainage, while the plug provides effective occlusion of the fistula tract. This combination achieves both continence preservation and high cure effectiveness
Solution Approach 2:
The device uses composite construction with the seton made of bioabsorbable material for temporary support and drainage, and the plug made of different material properties for permanent occlusion. This composite approach allows each component to optimize its function while working together to resolve the contradiction
3Object-affected harmful factors
If glues are injected into the fistula tract to occlude the tract, then the sphincter is preserved, but the glue becomes brittle and fails to occlude the tract long enough, resulting in reinfection
Solution Approach 1:
The seton is designed as a temporary, bioabsorbable component that provides short-term anchoring and drainage support. It is absorbed by the body after the plug has established permanent occlusion, eliminating the need for long-term foreign body presence while maintaining effective treatment during the critical healing period
4Reliability
If plugs are used to occlude perianal fistula tracts, then the tract is sealed, but the plugs become extruded from the tract, allowing faeces to enter and causing reinfection
Solution Approach 1:
The seton acts as an intermediary between the plug and the surrounding tissue. It anchors the plug in place within the fistula tract, preventing extrusion while maintaining the occlusion seal. The barbed design of the seton provides mechanical interlocking with the tissue, ensuring long-term stability of the plug position
Data Source
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AI summary
A perianal fistula treatment device consists of a coil and a drainage seton. The larger diameter of a tapered portion of the coil is abutted against the tissue surface surrounding the internal opening of the fistula tract. A delivery implement of the delivery mechanism rotates the coil. The implant coil has anti-rewind features 302. The coil closes the fistula internal opening by compressing the tissue surrounding the tract inwardly so that the tissue is brought within close approximation creating a seal impermeable to foreign materials and promoting tissue growth across the closely approximated fistula tract. A drainage seton may have anchoring features provided at a compression zone or region. The seton provides a conduit to drain any abscess and remaining or newly formed exudate and fluids from the fistula tract during the healing process.