Plastic-Embedded Lancet Needle In-Mold Sterilization
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Solution Overview
Problem
Existing methods for sterilizing medical devices with plastic-embedded needles, such as lancets, are inefficient and costly, particularly due to the need for separate post-manufacturing gamma radiation sterilization, which increases time and capital costs, and autoclaving damages the plastic components.
Innovation Solution
An intra-mold sterilization process where the needle is encapsulated in plastic within a mold, maintained at a specified temperature for a specified time to achieve sterilization during the manufacturing process, eliminating the need for post-manufacturing sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If autoclaving is used to sterilize the metal needle, then sterilization is achieved, but the plastic lancet body is damaged
Solution Approach 1:
The plastic body is pre-formed and cooled to a specific temperature range (below its melting point) before the metal needle is inserted. This preliminary preparation allows the needle to be sterilized in place without exposing the plastic to damaging autoclave temperatures, as the plastic has already been shaped and is maintained at a safe temperature throughout the sterilization process.
Solution Approach 2:
The sterilization process is segmented into two distinct phases: first, the plastic body is formed separately at safe temperatures; second, the metal needle is sterilized in place using a different method (chemical sterilization or lower-temperature autoclaving) that does not damage the already-formed plastic structure. This segmentation allows each component to be treated with the most appropriate sterilization method.
2Reliability
If gamma radiation sterilization is used after manufacture, then sterilization is achieved, but production time and costs increase
Solution Approach 1:
The manufacturing and sterilization processes are merged into a single integrated operation. The metal needle is sterilized in place within the molded plastic body using chemical sterilization agents or controlled-temperature autoclaving, eliminating the need for separate post-manufacturing gamma radiation sterilization. This combination reduces both time and capital costs by performing sterilization during the manufacturing cycle itself.
Solution Approach 2:
The plastic body is pre-cooled to a specific temperature range before needle insertion and sterilization. This preliminary temperature control enables the use of sterilization methods (such as chemical sterilization or moderate-temperature autoclaving) that can be performed immediately after manufacturing without requiring subsequent gamma radiation treatment, thereby shortening the production cycle.
3Productivity
If shorter in-mold cycle times are used, then production cost decreases, but sterilization effectiveness may be compromised
Solution Approach 1:
The sterilization parameters are optimized by controlling the plastic body temperature to be below its melting point but sufficient to allow effective sterilization of the metal needle. By adjusting temperature, chemical agent concentration, and exposure time parameters, the process achieves complete sterilization within the existing in-mold cycle time without requiring additional time, thus maintaining high production rates while ensuring sterilization effectiveness.
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 method allows for simultaneous manufacturing and sterilization of plastic-embedded needles, reducing production time and costs by ensuring the needle is sterilized within the mold, thus avoiding damage to plastic components and eliminating the need for additional sterilization steps.
Implementation Method 1
maintaining the formed product in the mold at at least a specified mold temperature for at least a specified cycle time, effective to sterilize the metal component
Data Source
AI summary
Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.