On-Off Valve for Injectable Bags Eliminates Needle Puncture
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The existing methods for preparing and diluting injectable products, which involve piercing bottle stoppers and bag membranes with metallic or plastic needles, are unsafe due to the risk of particle generation and contamination, and are prone to puncturing accidents, especially in uncontrolled environments.
Innovation Solution
A valve with an on-off mechanism for bags used in injectable product conditioning, reconstituting, and diluting, featuring a luer-lock terminal and protected by a cover, allows for access without needles or spikes, using a luer-lock syringe or infusion equipment, eliminating membrane punctures and enhancing safety through a 'No Coring Bag' design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If metallic or plastic needles are used to pierce bottle stoppers and bag membranes for preparing and diluting injectable products, then access to the product is achieved, but particle generation and contamination risks increase
Solution Approach 1:
The invention extracts and eliminates the need for pierceable membranes and stoppers from the system. Instead of using traditional rubber stoppers and membrane-sealed bags that require needle punctures, the invention employs screw-cap bottles and open-access bags with integrated valves, removing the source of particle generation entirely
Solution Approach 2:
The invention introduces an intermediate valve mechanism as a mediator between the bag and the administration system. This valve allows controlled access without direct needle-puncture of membranes, using a luer-lock connection system that prevents particle generation while maintaining sterile access
2Ease of operation
If metallic or plastic needles are used to pierce stoppers and membranes, then product access is enabled, but puncturing accidents and contamination likelihood increase
Solution Approach 1:
The invention employs disposable sterile connectors and valve systems that are designed for single use, eliminating the need to repeatedly sterilize and handle sharp needles. The luer-lock connectors are disposed of after single use, preventing contamination and puncturing accidents
Solution Approach 2:
The invention replaces the mechanical needle-puncture system with a threaded screw-cap system and a luer-lock valve system. These mechanical systems provide controlled access without sharp points, eliminating puncturing accidents while maintaining ease of operation
3Adaptability or versatility
If multiple opening and closure cycles are performed with traditional needle-puncture methods, then repeated access is achieved, but contamination and particle generation risks accumulate
Solution Approach 1:
The invention introduces a dynamic valve mechanism that can be opened and closed multiple times without compromising sterility. The valve allows controlled fluid passage when opened and maintains sealed closure when closed, enabling repeated access cycles without particle generation or contamination
Solution Approach 2:
The valve system serves multiple functions: it allows repeated opening for product access, maintains sterile closure when not in use, prevents backflow, and enables controlled administration. This multi-functional design eliminates the need for multiple punctures while supporting repeated access cycles
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 particle generation and contamination, ensuring safe handling and preparation of injectable products by eliminating the need for needle punctures, and is suitable for emergency situations by allowing multiple opening and closure cycles without leaks or safety hazards.
Implementation Method 1
A fluid flow control means is disposed with the body for controlling the flow of medical fluid materials through the hollow interior, between the medical fluid container and the medical accessory. The fluid flow control means comprises a valve member, a valve seat
Data Source
Figure 1
Figure 2~3
Figure 4
AI summary
"VALVE WITH ON-OFF MECHANISM FOR BAG USED FOR CONDITIONING, RECONSTITUTING AND/OR DILUTING OF INJECTABLE PRODUCTS" with the valve (3) integrated to the single access point (2) of a bag (1); the valve (3) includes an open-close mechanism that enables a syringe (S) or an infusion equipment (EI), both including a luer-lock terminal, to be directly coupled to said valve; the valve (3) comprises five basic components: the tapered base (4), the mobile tapered part (7), a smaller diameter sealing O-ring (13), a larger diameter sealing O-ring (12), and the cover (10) that protects the terminal (9) with a luer-lock type thread (8); the valve (3) removes the requirement of using metallic needles or plastic spikes during practical use of the bag (1).