Fistula Plug With Removable Core For Column Strength
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Solution Overview
Problem
Current methods for treating fistulae, such as surgical procedures and sealant injections, often result in complications like incontinence and infection flare-ups, and lack effective devices for plugging open spaces in the body, particularly in complex fistulae.
Innovation Solution
Development of medical devices, including fistula plugs and delivery apparatuses, that utilize a removable core material to increase column strength and facilitate delivery into fistula tracts, with configurations for push or pull delivery and optional protective sheaths to enhance placement and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a fistula plug is made with sufficient column strength to be delivered into complex fistula tracts, then delivery capability is improved, but the device complexity increases due to the need for removable core materials and delivery apparatuses
Solution Approach 1:
The fistula plug is divided into two functional components: a permanent plug body made of biocompatible material and a temporary removable core material. The core material provides structural support during delivery but is removed after implantation, allowing the plug to achieve sufficient column strength for complex tract delivery without permanently increasing device complexity.
Solution Approach 2:
The removable core material is pre-inserted into the plug body before delivery to provide the necessary column strength. This preliminary reinforcement enables the plug to withstand delivery forces through complex fistula tracts, and the core is subsequently removed to leave only the biocompatible plug body in place.
2Reliability
If surgical procedures are used to treat fistulae, then effective occlusion is achieved, but complications like incontinence and infection occur
Solution Approach 1:
A fistula plug serves as an intermediary device that occludes the abnormal fistula tract while preserving the integrity of surrounding healthy tissues and organs. Unlike surgical procedures that may damage sphincter muscles or create communication between organs, the plug provides targeted occlusion without causing incontinence or infection complications.
3Adaptability or versatility
If a fistula plug is designed for push or pull delivery through complex tracts, then delivery versatility is improved, but the ease of operation decreases due to the need for removable core materials
Solution Approach 1:
The plug body is designed with specific local qualities including a tapered distal end for easier insertion and a cylindrical proximal end for receiving the core material. The core material itself has local quality variations with a tapered distal end and cylindrical proximal end, allowing it to be easily inserted and removed while providing uniform structural support throughout the plug body during delivery.
Data Source
AI summary
The present invention provides, in certain aspects, medical devices deliverable into passageways and other open spaces in the body. In one embodiment, the invention provides a fistula plug for delivery into a fistula tract. This fistula plug includes an elongate plug body, and a removable core material that is received in the plug body and effective to increase the column strength of the plug body. The plug body may be formed with one or more of a variety of biocompatible materials including some that are naturally derived and some that are non-naturally derived. The present invention also provides apparatuses and methods for delivering these and other medical devices into the body. One such apparatus includes a fistula plug having a plug body, and a removable delivery device received in the plug body, wherein the delivery device is effective to deliver the plug body into a fistula tract when advanced therethrough.