Subdural Evacuation Port with Needle Access for Blockage Clearance
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Solution Overview
Problem
Existing devices for evacuating fluids from the subdural space often encounter blockages, such as blood clots, which can lead to incomplete fluid removal, increased pressure, and risk of brain damage, requiring removal and reinsertion of the device.
Innovation Solution
A subdural evacuation port system with a primary lumen and needle access ports that allow for the insertion of a needle to clear blockages without removing the device, using a polymer material that is rigid enough to sustain suction and compatible with CT scans, and includes features like self-tapping threads and optically transparent components for precise insertion and visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If a subdural evacuation device is used to remove fluid from the subdural space, then fluid evacuation is achieved, but blockages (e.g., blood clots) can occur within the subdural space or enter the evacuation device, preventing complete fluid removal
Solution Approach 1:
The evacuation device is divided into multiple lumens: a primary lumen for fluid evacuation and one or more secondary lumens for needle access. This segmentation allows the primary lumen to maintain continuous evacuation function while secondary lumens provide access for clearing blockages, ensuring both productivity and reliability.
Solution Approach 2:
A needle is introduced as an intermediary tool through the secondary lumen to access and clear blockages within the primary lumen. This intermediary mechanism allows removal of obstructions without requiring removal or replacement of the entire evacuation device, maintaining evacuation continuity.
2Reliability
If the evacuation device is removed and reinserted to clear blockages, then blockages can be removed, but this causes additional brain trauma and increases procedure time
Solution Approach 1:
The blockage clearance function is extracted from the main evacuation body by providing a separate secondary lumen with needle access. This allows the needle to be inserted through the secondary lumen to clear blockages in the primary lumen without removing the entire device, minimizing brain trauma while maintaining blockage clearance capability.
Solution Approach 2:
The evacuation device is designed with multi-functionality: the primary lumen performs fluid evacuation while the secondary lumen provides access for needle-based blockage clearance. This universal design combines multiple functions in one device, eliminating the need for device removal and reinsertion.
3Strength
If a rigid material is used to sustain suction pressure, then suction stability is achieved, but the device may not be compatible with CT scans
Solution Approach 1:
The device is constructed from composite materials that combine the necessary mechanical strength to sustain suction pressure with radiolucency for CT scan compatibility. This allows the device to maintain structural integrity during evacuation while being invisible or minimally interfering during imaging procedures.
4Stress or pressure
If the polymer material is made sufficiently rigid to sustain suction, then suction pressure is maintained, but the material must balance rigidity with biocompatibility and imaging compatibility
Solution Approach 1:
The polymer material parameters are optimized to achieve the right balance: sufficient rigidity to maintain suction pressure (typically 60-150 mmHg) while maintaining biocompatibility (low thrombogenicity) and radiolucency for imaging. The material properties are carefully selected and adjusted to meet multiple competing requirements simultaneously.
Data Source
AI summary
The present disclosure relates to a subdural evacuation port device for evacuating the subdural space of a patient. The device includes a body that includes: a distal opening at a distal end, a primary evacuation opening at a proximal end, a skull engagement region that at least partially surrounds the distal end of the body, and a primary lumen extending from the distal opening to the primary evacuation opening. The skull engagement regions is also configured to engage with a skull of a patient. The body is formed from a polymer that is sufficiently rigid to sustain suction in the lumen to allow withdrawal of subdural fluid from the distal opening through the primary lumen to a suction device connected to the primary evacuation opening.