Dural Sealing System with Guiding Thread and Transfer Device
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Solution Overview
Problem
Current dural sealing devices are complex, require manual dexterity, and have a high risk of implant migration, leading to ineffective sealing and potential neurological risks due to the lack of automated guidance and securement mechanisms.
Innovation Solution
A dural sealing system comprising an implant joined to a guiding thread, a transfer device with a nozzle for attaching to the epidural needle, and an introductory device with a tube to facilitate precise placement and securement of the implant, using a biocompatible and bioreabsorbable material, and a surgical sealant to prevent migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual dexterity and expertise are required for dural sealing operations, then the sealing process can be performed with basic device components, but the complexity of operation increases and success depends heavily on physician skill
Solution Approach 1:
The sealing device is divided into distinct functional segments: a delivery catheter for navigation, a sealing patch with adhesive layer for closure, and a retrieval mechanism. This segmentation allows each component to perform its specific function independently, simplifying the overall operation while maintaining device effectiveness
Solution Approach 2:
The sealing patch is pre-loaded onto the delivery catheter in a sterile, ready-to-deploy configuration. The adhesive layer is prepared in advance but remains protected until deployment, allowing the physician to perform the sealing action with a single straightforward motion rather than assembling multiple components during the procedure
2Productivity
If the epidural needle is removed immediately after intervention, then the procedure is completed quickly, but the dural puncture cannot be sealed effectively
Solution Approach 1:
The sealing patch is pre-positioned on the delivery catheter before needle removal. The catheter is advanced through the needle tract to the dural puncture site, and the patch is deployed immediately upon reaching the target, sealing the puncture before the needle is withdrawn. This preliminary preparation enables both rapid completion and effective sealing
Solution Approach 2:
The delivery catheter serves as an intermediary tool that bridges the gap between needle removal and puncture sealing. It provides a conduit for delivering the sealing patch to the exact location of the dural puncture, enabling the sealing action to occur at the precise moment when the needle is still in place but before it is removed
3Device complexity
If the sealing patch is manually introduced through the lumen of the epidural needle, then the device structure can be simple, but the operation becomes technically complicated and time-consuming
Solution Approach 1:
The sealing patch and delivery catheter are merged into a single integrated assembly where the patch is securely mounted on the catheter shaft. This combination eliminates the need for separate manipulation of multiple components during the procedure, reducing both device structural complexity and operational time
Solution Approach 2:
The delivery catheter is designed to self-position and self-deploy the sealing patch automatically as it is advanced through the needle tract. The physician simply needs to advance the catheter to the target site, and the patch deploys autonomously, eliminating the need for complex manual manipulation or additional deployment mechanisms
4Force
If the patch is pulled toward the dura mater by manually pulling the thread, then the sealing force can be controlled, but the risk of implant migration increases and the procedure requires steady hand and expertise
Solution Approach 1:
The delivery catheter provides tactile feedback to the physician during advancement, indicating when the sealing patch has reached the dural puncture site through resistance changes or positional markers. This feedback mechanism allows the physician to apply appropriate sealing force without requiring expert judgment or steady-handed manipulation
Solution Approach 2:
The delivery catheter acts as an intermediary that transfers and controls the deployment force to the sealing patch. Instead of the physician directly pulling on the patch or thread, the catheter mediates the force application, providing mechanical advantage and precise control over the deployment process, thereby reducing the skill requirement
Data Source
AI summary
The present invention refers to a dural sealing system (100) comprising an implant (10), joined to a guiding thread (20); a transfer device (30), provided with a grip portion (30a) and a hollow portion (30b), said hollow portion (30b) terminating, at a first end, in a nozzle (30c) that can be coupled to an epidural needle (200), said hollow portion (30b) also terminating in a second end fitted with an entry region (30d); and an introductory device (70) comprising a tube (70a) with a hollow interior section, provided with a first free end and a second closed end, attached to a stop (70b).