Needleless IV Injection Port with Compression-Fit Septum Seal
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Solution Overview
Problem
Conventional needleless injection ports have led to increased catheter-related bloodstream infections (CR-BSIs) and intraluminal thrombotic catheter occlusions, due to issues such as poor septum seal integrity, torturous fluid pathways, and neutral fluid displacement features that facilitate microbial contamination and blood reflux, which compromise patient safety and increase healthcare costs.
Innovation Solution
A needleless, intermittent injection port with a 3-piece component assembly featuring a compression-fit septum seal, a straight-through, reverse-split septum hollow fluid pathway cannula design, and reduced dead space, designed to prevent fluid leakage and improve back-pressure capabilities, while being latex-free and non-DEHP, Bisphenol-A free, and compatible with both male-luer lock and slip connectors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If conventional needleless injection ports are used to eliminate accidental needlestick injuries, then healthcare provider safety is improved, but catheter-related bloodstream infections and intraluminal thrombotic catheter occlusions increase
Solution Approach 1:
The injection port is divided into three separate components: a catheter hub portion, a septum portion, and a connector portion. This segmentation allows each component to be optimized independently - the septum can provide enhanced sealing and disinfection capabilities while the connector maintains sterile barrier integrity, thereby preventing CR-BSIs without compromising needleless safety
Solution Approach 2:
A disinfected flat septum surface acts as an intermediary between the external connector and the internal catheter hub. The septum provides a controlled interface that allows fluid passage while maintaining sterile barrier integrity and preventing microbial contamination, thus eliminating CR-BSIs while preserving the benefits of needleless access
2Object-affected harmful factors
If conventional needleless injection ports with torturous fluid pathways are used, then accidental needlestick injuries are prevented, but fluid flow rates decrease and dead space increases
Solution Approach 1:
The fluid pathway is segmented into distinct sections with a straight-through configuration in the catheter hub portion. This segmentation allows the fluid to flow directly from the catheter lumen through the hub to the septum without torturous paths, maintaining clinically acceptable flow rates while still providing needleless protection
Solution Approach 2:
Instead of designing a torturous pathway that forces fluid to navigate around obstacles, the invention inverts the approach by creating a direct, straight-through pathway. The safety features are integrated into the pathway geometry itself rather than being added as separate obstacles, thus maintaining flow velocity while preventing needlestick injuries
3Object-affected harmful factors
If conventional needleless injection ports with poor septum seal integrity are used, then accidental needlestick injuries are eliminated, but fluid leakage and microbial contamination increase
Solution Approach 1:
The flat septum surface is designed to be disinfected before connector attachment, performing the disinfection action in advance. This preliminary disinfection establishes a sterile barrier that prevents microbial contamination during the connection process, eliminating CR-BSIs while maintaining needleless safety
Solution Approach 2:
The disinfected flat septum serves as an intermediary sterile barrier between the non-sterile external environment and the sterile internal catheter system. This intermediary layer allows connector attachment and fluid passage while preventing microbial ingress, thus eliminating contamination risks without requiring needleless design compromises
4Object-affected harmful factors
If conventional needleless injection ports with neutral fluid displacement features are used, then accidental needlestick injuries are prevented, but blood reflux into the catheter increases
Solution Approach 1:
The injection port segments the fluid displacement control into the connector portion and catheter hub portion. The connector portion applies compression force that displaces fluid in a controlled manner, preventing blood reflux into the catheter while maintaining the needleless safety feature
Solution Approach 2:
The connector portion applies preliminary compression force in the direction that prevents blood reflux before reflux can occur. This preliminary anti-action counteracts the potential harmful effect of blood flowing back into the catheter, eliminating intraluminal thrombotic occlusions while preserving needleless protection
5Object-affected harmful factors
If conventional needleless injection ports with large dead space are used, then accidental needlestick injuries are eliminated, but priming volume increases and fluid flow efficiency decreases
Solution Approach 1:
Instead of designing a pathway that requires large priming volumes to fill torturous sections, the invention inverts the approach by creating a minimal dead space configuration. The straight-through pathway requires minimal priming volume while still providing adequate safety features, thus reducing the quantity of substance needed without compromising needleless protection
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 solution significantly reduces the risk of CR-BSIs and intraluminal thrombotic catheter occlusions by enhancing septum disinfection, minimizing fluid reflux, and maintaining clinically acceptable fluid flow rates, thereby improving patient safety and reducing healthcare costs.
Implementation Method 1
compression-fit septum seal
Implementation Method 2
compression-fit septum seal
Implementation Method 3
straight-through, reverse-split septum hollow fluid pathway cannula design
Implementation Method 4
resilient barrier(s) or seal(s) (i.e. silicone)
Data Source
Figure 1
Figure 2
Figure 3~3a
AI summary
An injection port assembly including a body having first and second mating structures configured to mate with a first connector for a first fluid pathway and a second connector on a device, respectively. A resilient barrier substantially contained within the body and compressible from a first position in which fluid flow between the first and second connectors is blocked to a more compressed second position in which fluid flow between the first and second connectors is permitted. A hollow cannula can be coupled with the first mating structure and disposed within the resilient barrier, the hollow cannula having a distal end configured to extend through the resilient barrier when the resilient barrier is in the second position, the distal end having lateral slots. The resilient barrier can have first and second annular sealing rings positioned above and below the lateral slots respectively.