Fistula Plug With Loop Elongate Member
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Solution Overview
Problem
There is a need for improved and alternative devices and methods for effectively addressing fistulae and other passageways and openings in the body, as existing solutions face challenges in securely implanting and fixing medical devices within complex fistula tracts.
Innovation Solution
The development of a medical device comprising a plug body and an elongate member, where the plug body is configured to fit within the fistula tract and the elongate member forms a looped assembly with the plug body to secure it in place, utilizing biodegradable materials that persist for at least 30 days to facilitate tissue integration and healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suturing methods are used to secure the plug body within the fistula tract, then the device can be firmly fixed in place, but patient discomfort increases and surgical complexity increases due to the need for suturing within the rectum
Solution Approach 1:
The patent introduces an elongate member as an intermediary element that connects the plug body to the fistula tract. This member acts as a mediator between the device and the tissue, providing secure fixation through a looped assembly that extends through the tract without requiring direct suturing within the rectum, thereby reducing patient discomfort while maintaining reliability
Solution Approach 2:
The device is segmented into distinct components: a plug body for occluding the fistula opening and an elongate member for securing it within the tract. This segmentation allows each component to perform its specific function independently, with the plug body providing the occlusion function and the elongate member providing the fixation function without requiring complex suturing operations
2Adaptability or versatility
If the plug body is made entirely from biodegradable materials to promote tissue integration, then patient comfort and tissue compatibility improve, but the device may lack sufficient structural strength for initial securing
Solution Approach 1:
The patent employs composite material construction where the plug body is made from biodegradable materials that promote tissue integration and compatibility. The elongate member may use different material properties optimized for mechanical strength during the initial healing period, creating a composite structure that balances both tissue adaptability and structural requirements
Solution Approach 2:
The device is designed with dynamic properties where the biodegradable materials gradually degrade over time as tissue integration occurs. The elongate member provides temporary structural support during the critical initial period, then progressively transfers its load-bearing function to the healed tissue as it degrades, creating a dynamic transition from device-supported to tissue-supported fixation
3Reliability
If the elongate member forms a looped assembly extending through the fistula tract to secure the plug body, then device fixation is improved without suturing, but the device complexity increases
Solution Approach 1:
The device is divided into two main segments: the plug body and the elongate member. This segmentation simplifies the overall design by allowing each component to have a single, well-defined function, reducing the complexity that would arise from attempting to integrate multiple functions into a single component
Solution Approach 2:
The elongate member serves as an intermediary element that simplifies the fixation mechanism. Instead of requiring complex suturing techniques, the intermediary member creates a simple looped assembly that can be inserted and secured through the fistula tract, reducing device complexity while maintaining reliable fixation
4Duration of action of moving object
If the biodegradable material is configured to persist for at least 30 days after implantation to facilitate healing, then tissue integration time is extended, but the device remains in the body longer potentially causing discomfort
Solution Approach 1:
The biodegradable material is designed with dynamic degradation properties that allow it to persist for the necessary 30+ days to facilitate complete tissue integration and healing. During this period, the material gradually transitions from providing full structural support to progressively transferring support to the healed tissue, minimizing discomfort while ensuring adequate healing time
Solution Approach 2:
The degradation rate and persistence duration of the biodegradable material are carefully controlled through parameter optimization. The material is engineered to maintain its structural integrity for at least 30 days to ensure proper tissue integration, then gradually degrades to eliminate the device from the body, balancing the need for extended integration time with the desire to minimize prolonged device retention
Data Source
AI summary
The present disclosure provides medical devices and methods for using said medical devices for treating a fistula in a patient. In some aspects the medical devices may include a plug body configured for receipt within the fistula tract, and an elongate member attached to a first location along the length of the plug body and configured to form a looped assembly extending through the fistula tract and along the path, wherein the looped assembly includes a length of the plug body that is free of the elongate member. In other aspects the medical devices may include a plug body having a longitudinal core in which portions of a plurality of biocompatible sheets are fixed to one another and also having a plurality of fin portions positioned or positionable to extend radially outward from the core in different directions.