Plastic-Embedded Needle Intra-Mold Sterilization During Molding

Solution Overview

Problem

Medical devices with plastic-embedded metal components, such as lancets, face challenges in sterilization due to the incompatibility of plastic with autoclaving heat, leading to increased costs and time requirements for gamma radiation sterilization.

Innovation Solution

An intra-mold sterilization process where a metal component is encapsulated in a mold cavity and maintained at a specified mold temperature for a cycle time to achieve sterilization during the manufacturing process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If autoclaving is used to sterilize the metal needle, then sterilization is achieved, but the plastic lancet body is damaged

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidplastic body integrity

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The sterilization process is segmented into two separate operations: the metal needle is sterilized independently (either before or during molding), and the plastic body is molded separately. This allows each component to undergo appropriate sterilization without exposing the plastic to damaging autoclave temperatures, thus resolving the contradiction between achieving sterilization and preserving plastic integrity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The metal needle is sterilized in advance, prior to being embedded in the plastic body. This preliminary sterilization action ensures the needle is sterile before assembly, eliminating the need for post-assembly autoclaving that would damage the plastic. The sequence of operations is rearranged to perform sterilization when it will not harm other components.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If gamma radiation sterilization is used after manufacture, then sterilization is achieved, but manufacturing time and cost increase

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidmanufacturing cycle time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The sterilization process is merged with the manufacturing process by incorporating sterilization steps within the molding operation itself. The metal needle is sterilized either before insertion into the mold or during the molding cycle, combining two previously separate operations (sterilization and manufacturing) into one integrated process, thereby eliminating additional sterilization time and reducing overall manufacturing cycle time.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The metal needle is sterilized in advance, prior to being embedded in the plastic body. This preliminary sterilization action ensures the needle is sterile before assembly, eliminating the need for post-assembly autoclaving that would damage the plastic. The sequence of operations is rearranged to perform sterilization when it will not harm other components.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If gamma radiation sterilization is used, then sterilization is achieved, but manufacturing cost increases

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidmanufacturing cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The sterilization process is merged with the manufacturing process by incorporating sterilization steps within the molding operation itself. The metal needle is sterilized either before insertion into the mold or during the molding cycle, combining two previously separate operations (sterilization and manufacturing) into one integrated process, thereby eliminating additional sterilization time and reducing overall manufacturing cycle time.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The manufacturing process itself provides the sterilization function. By controlling the mold temperature and cycle time appropriately, the molding process inherently sterilizes the metal needle component, making the process self-sufficient and eliminating the need for separate, expensive gamma radiation sterilization equipment and operations.

Inventive Principle:

Principle #25Self-service

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

Enables simultaneous manufacturing and sterilization of plastic-embedded needles, eliminating the need for post-manufacturing sterilization and reducing costs by integrating sterilization into the molding process.

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

Methodology Applied

Scientific EffectThermal sterilization: Heating

Data Source

PatentUS20260060577A1Intra-mold sterilization of plastic-embedded needle

Publication Date: 2026.03.05 FACET TECH LLC

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.