Passive Huber Needle Safety Mechanism for Single-Hand Removal
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Solution Overview
Problem
Existing Huber needle assemblies require clinicians to use both hands for removal and protection, posing risks due to the need for manual operation and potential rearming of safety devices, as well as resistance from the silicone compound in subcutaneous ports, which can lead to accidental needle exposure.
Innovation Solution
A passive safety mechanism that automatically locks the needle in a safe position upon removal from the skin, allowing a single clinician to initiate and complete the removal and flushing process without assistance, utilizing a main body with a securement door, hinge mechanisms, and a biasing member to ensure the needle is covered and locked.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a latching safety capture device is used to protect the needle, then the clinician is protected from accidental needle sticks, but the device requires two hands to operate and can be rearmed by defeating the latching feature
Solution Approach 1:
The safety mechanism automatically activates to cover and lock the needle upon extraction from the port, eliminating the need for manual operation by the clinician. The spring-loaded cover is biased to automatically engage with the main body, securing the needle without requiring clinician intervention.
Solution Approach 2:
The safety cover is pre-positioned in a retracted state during insertion, and the latching mechanism is pre-configured to automatically engage upon extraction. This preliminary arrangement ensures immediate protection upon needle removal without requiring manual activation.
2Reliability
If a strong spring is used to force the needle through the latching cover, then the needle capture rate is assured, but the patient may be pinched by the swing arm traveling and pinning skin between the needle and the arm
Solution Approach 1:
The swing arm is designed to dynamically adjust its position during needle extraction. The arm pivots on an axle and can rotate to accommodate the needle's movement, preventing the needle from becoming pinned between the arm and the patient's skin while still maintaining sufficient spring force for reliable capture.
Solution Approach 2:
The safety mechanism is divided into separate functional components: the main body housing, the movable cover, the swing arm, and the spring mechanism. This segmentation allows each component to perform its specific function independently, with the swing arm specifically designed to move freely to prevent skin pinching while the spring provides the necessary force for needle capture.
3Ease of operation
If the clinician uses both hands to remove the needle to prevent pain and manipulate the safety device, then patient comfort is improved, but the clinician cannot simultaneously flush the needle to prevent thrombus formation
Solution Approach 1:
The safety mechanism performs the protective function automatically during needle extraction, freeing the clinician's hands to simultaneously perform flushing through the hub. The automatic cover engagement and locking mechanism operate without requiring clinician manual manipulation, enabling concurrent flushing to prevent thrombus formation.
4Duration of action of stationary object
If the silicone compound is inserted under pressure to extend port life, then the port useful life is extended, but the resistance to needle extraction increases creating safety risks
Solution Approach 1:
The spring-loaded safety cover is pre-positioned and biased to automatically engage upon needle extraction. This beforehand preparation ensures that the safety mechanism is ready to immediately capture and protect the needle the moment it clears the silicone barrier, compensating for the high extraction resistance without requiring additional manual force from the clinician.
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
Enables safe and efficient removal and protection of the needle with a single clinician, reducing the risk of accidental exposure and allowing for effective flushing to prevent thrombus formation and occlusion, while maintaining a similar height profile to non-safety devices.
Implementation Method 1
a biasing member, such as a spring, lever, or other biasing member, to urge the movable cover to the open position
Data Source
AI summary
A safety needle system includes a safety mechanism for a needle assembly, such as a Huber needle. A main body has a channel having a proximal end to encompass tubing and a distal end for positioning proximate a needle. The main body further has a first hinge mechanism and a first latching mechanism. A movable cover has needle receptacle, a second hinge mechanism connected with the first hinge mechanism of the main body, and a biasing member for pivoting movable cover about the first and second hinge mechanisms relative to the main body. The movable cover has a second latching mechanism to latch with the first latching mechanism in a closed position, in which the safety mechanism can be undocked from the needle and slid away from the needle along the tubing. The movable cover has a release mechanism to allow pivoting of the movable cover about the hinge mechanisms such that the needle receptacle of the movable cover at least partially receives the needle of the needle assembly in an open, locked position.