Intra-mold sterilization of plastic-embedded needle

Inventors

Seifert, Kevin J.

Assignees

Facet Technologies LLC

Abstract

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.

Core Innovation

The invention relates to a method for manufacturing a sterile lancet by performing sterilization during injection molding. A lancet needle is retained within a mold cavity of a mold, and plastic is injected to form a lancet body substantially encapsulating the needle therein. The mold is operated to hold a specified minimum mold temperature for a specified minimum cycle time effective to sterilize the lancet needle during manufacture.

A key aspect is that the mold includes means for maintaining the specified minimum mold temperature for the specified minimum cycle time, and this means is embedded within the mold adjacent to the mold chamber. This embedded placement is arranged such that the plastic does not come into direct contact with the means for maintaining the specified minimum mold temperature.

The disclosed approach uses injection molding conditions in which temperature and time thresholds are specified to achieve sterilization without separate post-manufacturing sterilization. The description further indicates the use of heating elements and/or hot runners to maintain the mold/plastic temperature, followed by cooling and ejection of the lancet from the mold.

Claims Coverage

The document includes one independent claim (clm-00001) directed to a method for manufacturing a sterile lancet, with several dependent claims refining temperature/time thresholds and mold/temperature-maintaining structures and mold-chamber portions. The inventive features across the independent claim can be captured as retaining and encapsulating a needle while sterilizing it via specified minimum mold temperature and minimum cycle time maintained by embedded means adjacent the mold chamber without direct plastic contact.

Overall, the claim coverage centers on manufacturing a sterile lancet by combining needle retention in a mold cavity, injection molding to encapsulate the needle in a lancet body, and achieving sterilization during manufacture by maintaining specified minimum mold temperature for a specified minimum cycle time using embedded temperature-maintaining means positioned adjacent the mold chamber while preventing direct plastic contact.

Stated Advantages

Documented Applications