Needle Safety Footplate for Automatic Flow Occlusion
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Solution Overview
Problem
Existing vascular connection systems fail to reliably detect and interrupt dislodged needles, posing safety risks during medical procedures by allowing errant fluid flow.
Innovation Solution
A tissue access device with a spring-loaded footplate mechanism that senses skin contact to automatically occlude fluid flow when dislodged, using a two-shot molding technique for efficient manufacturing and incorporating a flexible membrane to block flow path changes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a mechanically based sensing system with spring-loaded footplate is used to detect needle dislodgement, then patient safety is improved through automatic flow interruption, but device complexity increases due to additional mechanical components
Solution Approach 1:
The patent combines the sensing function and flow occlusion function into a single integrated footplate mechanism. The footplate serves dual purposes: it senses needle dislodgement through its spring-loaded contact with the patient's skin and simultaneously occludes flow by blocking the fluid pathway when dislodged. This merging eliminates the need for separate sensing and occlusion mechanisms, reducing overall device complexity while maintaining reliability.
Solution Approach 2:
The footplate mechanism is designed to automatically detect needle dislodgement and trigger flow occlusion without requiring external sensors or control systems. The mechanical spring-loaded footplate self-activates the occlusion function through its own movement when dislodged from the patient's skin, making the system self-sufficient and reducing complexity by eliminating external monitoring equipment.
2Reliability
If a flexible membrane occluder is used to block fluid flow path, then flow interruption effectiveness is improved, but manufacturing complexity increases due to two-shot molding requirements
Solution Approach 1:
The two-shot molding process pre-forms the flexible membrane occluder with its specific geometry and material properties during manufacturing. The first shot creates the rigid support structure while the second shot forms the flexible membrane portion with precise thickness and curvature. This preliminary action during manufacturing ensures the occluder has the exact characteristics needed for effective flow blocking without requiring additional post-processing or assembly steps.
Solution Approach 2:
The occluder is constructed as a composite structure with two different materials: a rigid material for the support framework and a flexible material for the membrane portion. This composite construction allows the rigid parts to provide structural integrity while the flexible membrane provides the sealing and blocking function. The two-shot molding process is specifically designed to create such composite structures with precise material interfaces.
3Measurement precision
If external actuation systems with continuity sensors are used to detect dislodged connections, then detection capability is improved, but device complexity and cost increase
Solution Approach 1:
The patent replaces complex external actuation systems and electronic continuity sensors with a simple mechanical spring-loaded footplate system. Instead of using electrical currents, capacitance sensors, or ultrasound to detect dislodgement, the invention uses the mechanical movement of the footplate itself to both sense and respond to needle dislodgement. This substitution dramatically reduces device complexity and cost while maintaining detection precision.
Solution Approach 2:
The footplate mechanism serves its own sensing function without requiring external monitoring equipment. The mechanical displacement of the footplate when dislodged directly triggers the occlusion action, eliminating the need for external sensors, actuators, or control systems that would otherwise be required to detect and respond to connection status changes.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively prevents errant fluid flow by automatically shutting off fluid delivery when a needle is dislodged, enhancing patient safety and reducing manufacturing complexity and costs.
Implementation Method 1
A spring-loaded footplate affixed to the bottom of a needle is one of several means by which to perform this sensing operation
Implementation Method 2
The deformable membrane and the first-shot mold can define a device flow channel
Data Source
Figure 1
Figure 2A~2C
Figure 3A~3B
AI summary
Tissue access devices and methods of using and making the same are disclosed. The devices can have a sensor configured to occlude a flow path by deflecting a membrane into the flow path when the devices become dislodged from tissue. The sensor can be configured to partially or fully occlude the flow path. The sensor can have a spring, can be a spring, or may not have a spring. The sensor can be static or can be moved from a sensor first configuration to a sensor second configuration. The membrane can be deflected into the flow path when the sensor is in the sensor second configuration.