Safety Needle Assembly Using Two Sub-Assemblies for Sterile Packaging
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Solution Overview
Problem
The assembly of spring-activated safety needle devices is complex and costly due to the intricate positioning and tensioning of metal springs, which increases production time and requires numerous quality checks, thereby reducing assembly line speed and increasing costs.
Innovation Solution
A method involving the formation of two sub-assemblies, where the first sub-assembly is assembled separately and then united with a second sub-assembly on a distinct assembly line, utilizing an interference fit and alignment of central longitudinal axes to simplify the process, reduce inspections, and maintain sterility, allowing for faster assembly and packaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If metal springs are used to actuate the shielding arrangement and pivot/tilt the needle, then needlestick protection is provided, but assembly complexity increases and assembly line speed decreases
Solution Approach 1:
The assembly process is divided into two separate sub-assemblies: a first sub-assembly containing the spring-activated shielding mechanism and a second sub-assembly containing the needle and mount. These are then united on a distinct assembly line, reducing the complexity of any single assembly operation and allowing for specialized optimization of each stage.
Solution Approach 2:
The first sub-assembly is pre-assembled and pre-positioned on the assembly line before the needle is inserted. This preliminary preparation eliminates the need for complex spring positioning operations during the main assembly process, reducing overall assembly complexity while maintaining the reliable needlestick protection function.
2Reliability
If numerous quality checks are performed at each assembly stage, then product quality is ensured, but assembly cost increases and assembly line speed decreases
Solution Approach 1:
By segmenting the assembly into two separate sub-assemblies that are united on a distinct assembly line, quality checks can be optimized at each stage. The first sub-assembly can be quality-checked independently, then the second sub-assembly is assembled and quality-checked as a final unit, reducing the total number of inspection steps compared to continuous monitoring at every minor operation.
Solution Approach 2:
The interference fit mechanism between the first and second sub-assemblies provides self-alignment and self-verification during assembly. The central longitudinal axes automatically align during the uniting process, reducing the need for complex quality checks while ensuring proper positioning and maintaining assembly line speed.
3Ease of manufacture
If the container is opened to allow assembly operations, then assembly access is improved, but sterility is compromised
Solution Approach 1:
The assembly process is segmented into operations performed on the closed container and operations performed after opening. The first sub-assembly is assembled and positioned within the closed container, maintaining sterility. Only after the container is opened is the needle inserted and the final assembly completed, minimizing the time the container is open and reducing sterility compromise.
Solution Approach 2:
The first sub-assembly is pre-assembled and positioned within the closed container before opening occurs. This preliminary action allows assembly operations to be performed while maintaining sterility, and only the final needle insertion requires the container to be open, thus preserving sterility as much as possible during manufacturing.
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 approach speeds up the assembly process, reduces the number of quality checks, and minimizes production costs while ensuring reliable needlestick protection, enhancing the efficiency and cost-effectiveness of safety needle device manufacturing.
Implementation Method 1
a spring means to urge movement of the double ended needle during use to a shielding position
Implementation Method 2
The greater the number of assembly steps the greater the number of quality checks need to be completed
Data Source
AI summary
The present invention provides a method of assembling and packaging a medical needle device having a double ended needle (116), which comprises a container (170) having a closed end and an open end to receive a spring activated safety needle device (110) to provide passive needlestick protection to a non-patient end (118) of the needle (116). The method comprises performing the independent steps of (i) assembling a first sub-assembly (101) by mounting a shield (114) to a tubular housing (130) to form a telescopic device (104) and engaging the telescopic device (104) within the container (170), and (ii) assembling a second sub-assembly (102) by securing the double ended needle (116) within the needle mount (140), wherein the mounting element is provided on an external surface of the needle mount (140). The tubular housing (130) comprises (a) a mounting member on an internal surface to engage a mounting element of the needle mount (140), and (b) a spring to urge movement of the double ended needle (116) during use to a shielding position whereat the needle (116) extends at an angle oblique to a longitudinal axis of the tubular housing (130) to place the non-patient end (118) of the needle (116) at a location adjacent to an interior wall of the tubular housing (130). The method further comprises inserting the second sub-assembly (102) into the tubular housing (130) to secure the mounting element of the needle mount (140) to the mounting member of the tubular housing (130) to unite the second sub-assembly (102) to the first sub-assembly (101) to enable the spring to urge movement of the double ended needle (116) during use to a shielding position. Finally, the method comprises applying the closure a label (124) over the open end of the container (170) to seal the medical needle device 110 within the container (170).