Blister Pack Blood Collection Set with Integrated Needle Shield
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Solution Overview
Problem
The high manufacturing and packaging costs of blood collection sets make them unaffordable for economically disadvantaged communities, leading to potential health risks from reused components and cross-contamination due to the absence of proper needle shields.
Innovation Solution
An integrated low-cost blood collection set with a thermoformed blister pack that combines the needle cannula, hub, and shield, eliminating the need for separate components and assembly, and serving as both a holder and shield for the needle cannula during and after use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate components (holder, needle assembly, shield) are manufactured and assembled, then the blood collection set can perform its function, but the manufacturing cost and assembly complexity increase
Solution Approach 1:
The patent combines the holder, needle assembly, and shield into a single integrated sterile barrier system. The back cover is molded with an integrated hub that receives the needle assembly, and the frangible portion provides the shield function. This merging eliminates the need for separate components and assembly steps while maintaining all necessary functions for safe blood collection.
Solution Approach 2:
The back cover serves multiple functions simultaneously: it acts as the holder body, provides the hub for needle attachment, incorporates the shield through the frangible portion, and includes the collection tube receptacle. This multi-functionality reduces the overall component count while ensuring reliable blood collection capability.
2Ease of manufacture
If components are separately manufactured and packaged, then each component can be optimized, but the packaging cost and assembly time increase
Solution Approach 1:
The holder, hub, and shield are pre-integrated into a single molded back cover structure before packaging. The needle assembly is pre-attached to the hub in a sterile manner during manufacturing. This preliminary integration eliminates the need for assembly operations at the point of use, reducing assembly time while allowing each sub-component to be optimized during the molding process.
3Reliability
If a needle shield is included, then proper disposal and safety are ensured, but the manufacturing cost increases
Solution Approach 1:
The shield function is merged into the back cover structure through the frangible portion. When the frangible portion is broken, it allows access to the needle assembly for use, and after use, the back cover can be folded back to enclose and shield the needle. This integration eliminates the need for a separate shield component, reducing manufacturing cost while ensuring safe disposal capabilities.
4Ease of manufacture
If the holder is reused to save costs, then manufacturing costs decrease, but health risks and cross-contamination increase
Solution Approach 1:
The back cover is designed as a disposable sterile barrier system. The frangible portion is broken during initial use to expose the needle, and after the procedure, the entire back cover with the needle assembly is discarded. This disposable design prevents reuse while maintaining low manufacturing costs, eliminating cross-contamination risks associated with repeated sterilization and reuse.
Solution Approach 2:
The back cover is pre-packaged in sterile condition with the needle assembly attached. The frangible portion is designed to be broken only during the intended use, ensuring sterility is maintained until that moment. After use, the entire unit is discarded, preventing any possibility of reuse and cross-contamination while keeping the system affordable.
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
This solution reduces manufacturing costs, prevents reuse of components, and ensures proper disposal of needles, thereby enhancing safety and accessibility of blood collection sets while maintaining sterility.
Implementation Method 1
a package at least partially enclosing the needle cannula and the hub. The package includes at least one openable region configured for receiving a fluid collection device therein
Data Source
AI summary
A low cost fluid collection set having an integrated package including a needle cannula having a first end and a second end, a hub configured for supporting the needle cannula, and a package at least partially enclosing the needle cannula and the hub is disclosed. The package includes at least one openable region configured for receiving a fluid collection device therein wherein this openable region is in communication with at least one of the first end or the second end of the needle cannula and wherein the package is configured to be used as a holding device to manipulate the needle cannula during fluid collection. The package also functions as a shield for the first end of the needle cannula after use. A method of using the fluid collection set having an integrated package and a method of making the fluid collection set is provided.