Laser Marking of Elastomer Components Without Leachable Labels
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Solution Overview
Problem
Existing methods for serializing or marking medical device components, such as RF tags, labels, and surface printing, face issues like high costs, adhesion risks, wear, and surface morphology impacts, which can compromise product safety and sealing integrity.
Innovation Solution
A method involving the use of a UV laser to create visible marks on elastomer components, which are partially formed from markable materials that change color upon exposure to UV light, allowing for safe, clean, and sterilization-compatible marking, even under pre-applied films, thereby minimizing risks of leachable materials and ensuring compatibility with cryogenic applications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If surface printing is used to mark medical device components, then identification information can be applied, but leachable material is created and surface morphology is altered
Solution Approach 1:
The patent replaces mechanical surface printing with laser marking technology. The laser beam directly modifies the elastomer material through ablation or color change without requiring physical contact or adhesive materials, thereby eliminating leachable contaminants while maintaining identification information.
Solution Approach 2:
The patent changes the physical state of the elastomer material through controlled laser irradiation. By adjusting laser parameters (wavelength, power, pulse duration), the material undergoes localized color change or ablation to create permanent marks without introducing foreign substances that could leach.
2Loss of information
If labels are applied to medical device components, then serialization is achieved, but adhesion risks allow material to leach into drugs
Solution Approach 1:
The patent replaces adhesive-based label application with direct laser marking on the component surface. This eliminates the adhesion interface entirely, removing the risk of label material detaching or leaching into the drug while preserving serialization capability through permanent marks.
3Loss of information
If mold cavity identification is used, then component tracking is possible, but the identification wears down over time
Solution Approach 1:
The patent replaces mechanical mold cavity embossing with laser marking. The laser-induced modifications create marks that are resistant to wear from handling, sterilization, and use, significantly extending the functional lifetime of the identification while maintaining tracking capability.
4Loss of information
If RF tags are used for serialization, then unique identification is achieved, but the tags are expensive and difficult to apply at scale
Solution Approach 1:
The patent replaces RF tag application with integrated laser marking. This eliminates the need for separate tag attachment steps, reducing manufacturing complexity and cost while achieving unique identification through direct marking on the component itself.
Solution Approach 2:
The patent combines the identification function directly into the component manufacturing process through laser marking, rather than adding a separate RF tag layer. This integration reduces the number of manufacturing steps and eliminates the costs associated with tag materials and application equipment.
5Illumination intensity
If marking is performed before film application, then the mark is visible, but the film may interfere with subsequent processing
Solution Approach 1:
The patent performs laser marking after film application by selecting a laser wavelength that penetrates the film material. This preliminary action of choosing the right wavelength allows the mark to be created through the film without compromising either visibility or the ability to perform subsequent processing steps.
Solution Approach 2:
The patent changes the laser wavelength parameter to match the transmission characteristics of the film material. By selecting a wavelength where the film is transparent or semi-transparent, the laser can mark the underlying elastomer while the film remains intact for its intended functions.
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 enables precise, safe, and durable marking of medical device components, reducing the risk of contamination and ensuring compatibility with various materials and applications, while maintaining product integrity and safety.
Implementation Method 1
exposing one or more areas of the at least a portion of the markable material to laser irradiation of a predetermined wavelength to form a visible mark on the surface of the body by changing the one or more areas to a second color different from the first color
Implementation Method 2
the film having a transmittance at the predetermined wavelength of ultraviolet light of at least 5%
Data Source
AI summary
A system for manufacturing elastomeric components is provided. The system may include a molding station having a mold configured to receive an elastomeric material, form a pad that includes a plurality of untrimmed elastomeric components, and cure the pad. The system may further include an automated marking station comprising a laser and a camera. The automated marking station may be configured to remove the cured pad from the molding station, present the cured pad to the laser to form a mark on each of the untrimmed elastomeric components, and present the cured pad to the camera to capture an image of each mark. A process for manufacturing the elastomeric components is also provided.