Intra-mold sterilization of plastic-embedded needle
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Publication Number
US-10779758-B2
Publication Date
2020-09-22
Expiration Date
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 intra-mold sterilization for manufacturing medical devices that include plastic-embedded metal components. A metal component is retained within a mold cavity configured to receive the metal component, and plastic is injected into the mold cavity to substantially encapsulate the metal component with plastic. The injected plastic within the mold cavity is heated to a specified minimum temperature and maintained at the specified minimum temperature for a specified minimum cycle time effective to sterilize the metal component during molding.
The mold comprises a heating element embedded in the mold adjacent to the mold cavity. The heating element is configured to heat the injected plastic within the mold cavity without contact with the injected plastic. This enables sterilization of the metal component as part of the plastic molding process while the metal component is retained in the mold cavity and encapsulated by the injected plastic.
The disclosed manufacturing context includes a plastic-embedded metal component example in the form of a lancet, where a metal needle is encapsulated in an injection-molded plastic body. The document also describes an example configuration with a removable endcap covering a needle tip. By applying the intra-mold heating and maintaining the specified minimum temperature for the specified minimum cycle time, the approach is described as eliminating post-manufacturing sterilization such as autoclaving or gamma radiation for achieving a sterile product.
Claims Coverage
The document includes one independent claim with multiple dependent claims. The independent claim focuses on sterilizing a metal component during molding by encapsulation with injected plastic and maintaining a specified minimum temperature for a specified minimum cycle time using an embedded mold heating element that heats the plastic without contact. Dependent claims further specify the medical device type as a lancet and an optional removable endcap, and add quantitative minimum temperature and minimum cycle time bounds.
Encapsulating a metal component in injected plastic within a mold cavity for in-mold sterilization
Retaining a metal component within a mold cavity of a mold configured to receive the metal component, injecting plastic into the mold cavity to substantially encapsulate the metal component with plastic, and heating the injected plastic within the mold cavity to a specified minimum temperature and maintaining the specified minimum temperature for a specified minimum cycle time effective to sterilize the metal component.
Heating the injected plastic without contact using an embedded heating element adjacent to the mold cavity
A mold comprising a heating element embedded in the mold adjacent to the mold cavity, wherein the heating element is configured to heat the injected plastic within the mold cavity without contact with the injected plastic.
Across the independent claim, sterilization is achieved as part of molding by encapsulating a retained metal component with injected plastic and maintaining a specified minimum temperature for a specified minimum cycle time effective to sterilize the metal component, using an embedded mold heating element that heats the injected plastic without contact. Dependent claims further constrain the device structure as a lancet and may include a removable endcap, and add minimum temperature and cycle-time bounds.
Stated Advantages
Eliminating post-manufacturing sterilization such as autoclaving or gamma radiation.
Documented Applications
Manufacturing medical devices with plastic-embedded metal components, including an example lancet with a metal needle embedded in a plastic body and optionally a removable endcap covering the needle tip.
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