Laser-Marked Elastomer Components Under Transmissive Film
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Solution Overview
Problem
Existing methods for serializing or marking medical device components, such as RF tags, labels, mold cavity identification, and surface printing, face challenges like high costs, adhesion issues, wearability, limited information capacity, and potential leachable material that can impact drug safety and sealing performance.
Innovation Solution
A method involving the use of a markable material in medical device components that changes color when exposed to laser irradiation of a specific wavelength, allowing for the creation of visible marks under a pre-applied film, which can contain data related to manufacturing steps and other relevant information.
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 to the component surface, but leachable material is created and surface morphology differences impact sealing or machinability
Solution Approach 1:
The patent replaces traditional mechanical surface printing methods 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 capability
Solution Approach 2:
The patent utilizes laser parameters (wavelength, power, pulse duration) to induce controlled changes in the elastomer material properties. By adjusting these parameters, the laser creates permanent color changes or ablation patterns that provide identification without introducing harmful leachable materials
2Loss of information
If labels are applied to medical device components for serialization, then identification information can be added, but adhesion issues arise and labels can fall off during sterilization or use
Solution Approach 1:
The patent replaces the mechanical adhesion system (labels bonded to surfaces) with a direct laser marking system that creates permanent modifications in the elastomer material itself, eliminating adhesion failures during sterilization and use
Solution Approach 2:
The patent merges the identification information directly into the elastomer material structure through laser-induced color changes or ablation patterns, making the marking an integral part of the component rather than a separate applied layer
3Loss of information
If RF tags are used for component identification, then data storage capability is improved, but the tags are expensive and difficult to apply at scale
Solution Approach 1:
The patent replaces electronic RF tag systems with optical laser marking technology, achieving data storage through visual patterns (barcodes, data matrices) that can be rapidly applied during manufacturing without additional components or complex assembly steps
Solution Approach 2:
The patent uses a cost-effective laser marking approach that eliminates expensive RF tag components, replacing them with simple optical patterns that provide sufficient identification capability at a fraction of the cost
4Ease of manufacture
If mold cavity identification is used for component marking, then manufacturing process integration is improved, but the markings wear down over time and provide limited information
Solution Approach 1:
The patent performs laser marking as a preliminary action during or immediately after the molding process, ensuring the identification information is established before the component enters service, where it will be protected from wear by the elastomer material itself
Solution Approach 2:
The patent uses controlled laser parameters to create durable color changes or ablation patterns within the elastomer material that resist wear over time, unlike surface-level mold cavity markings
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 solution provides a safe, clean, and sterilization-compatible method for marking medical device components, minimizing the risk of leachable material and ensuring durability across various manufacturing processes and applications, including cryogenic environments.
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 medical device component is provided. The medical device component may include a body having a first surface being at least partially formed from a markable material having a first color, the markable material having a characteristic that an area exposed to laser irradiation of a predetermined wavelength of ultraviolet light changes to a second color different from the first color; a film covering at least a portion of the first surface of the body, the film having a transmittance at the predetermined wavelength of ultraviolet light of at least 5%; and a visible mark on the markable material at the first surface of the body covered by the film. The visible mark may include one or more areas of the markable material at the first surface having the second color. Methods of manufacturing the medical device component are also provided.