Multi-layered Medical Assembly Peel Control
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Solution Overview
Problem
Existing polymer films used in medical dressings and drapes face issues with wrinkling and creasing due to inadequate peel control, particularly after sterilization and temperature fluctuations, which affect the bond strength between the film and the carrier, making removal impractical.
Innovation Solution
A multi-layered assembly featuring a heat sealable layer with a partially salt neutralized ionomer provides a non-permanent bond between the carrier and the polyurethane film, maintaining a consistent peel force across various temperatures and sterilization methods, ensuring easy removal without wrinkling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a carrier is applied to the polymer film to prevent wrinkling, then the film integrity during application is improved, but the bond strength between carrier and film becomes too strong making removal impractical
Solution Approach 1:
The patent applies a heat sealable layer comprising a partially salt neutralized ionomer that changes its bonding characteristics based on temperature. At sterilization temperatures, the layer forms a strong bond to prevent wrinkling, but at lower temperatures during application and removal, the bond strength is reduced to allow practical handling and removal without creasing the film.
Solution Approach 2:
The bonding system transitions from a static strong bond to a dynamic system where bond strength can be modulated by temperature. The heat sealable layer provides a releasable bond that is strong during sterilization but becomes weaker at operating temperatures, enabling the carrier to be removed without damaging the film.
2Reliability
If the bond strength between carrier and film is increased to maintain integrity during sterilization, then sterilization durability is improved, but the peel force becomes too high for practical removal
Solution Approach 1:
The heat sealable layer utilizes temperature-dependent bonding parameters. During sterilization at elevated temperatures, the ionomer forms strong bonds ensuring durability. During removal at lower temperatures, the bond strength decreases to provide a practical peel force within the desired range of 50-600 grams/inch.
3Force
If the peel force is reduced to enable easy removal, then ease of removal is improved, but the bond strength becomes insufficient to prevent wrinkling during application
Solution Approach 1:
The system employs a dynamic bonding mechanism where the heat sealable layer provides strong adhesion at sterilization temperatures to prevent wrinkling, then transitions to a weaker bond at lower temperatures that enables easy removal with controlled peel force.
4Adaptability or versatility
If the bond strength varies with temperature fluctuations, then adaptability to different conditions is improved, but peel force control becomes unpredictable affecting removal consistency
Solution Approach 1:
The partially salt neutralized ionomer in the heat sealable layer provides controlled parameter changes with temperature. The material is specifically selected to maintain peel force within the 50-600 grams/inch range across temperature variations from sterilization to storage conditions, ensuring both adaptability and consistency.
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
The multi-layered assembly maintains a consistent peel force of 50-600 grams/inch, varying by less than 25% with temperature changes and showing minimal variation after sterilization, ensuring practical and aseptic application of medical dressings.
Implementation Method 1
a heat sealable layer disposed between the carrier and the polymeric film... provides a non-permanent bond between the carrier and the polyurethane film
Implementation Method 2
the peel force can vary by less than 25% when the temperature of the assembly is raised from room temperature (e.g., 25 C) to about 55-65 C
Implementation Method 3
the peel force can vary by less than 10% when the assembly is subjected to gamma ray sterilization
Data Source
Figure 1
Figure 1A
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AI summary
Embodiments disclosed herein provide for multi-layered assemblies comprising a carrier having opposed sides; a heat sealable layer disposed on at least a portion of one of said sides of the carrier, said heat sealable layer comprising a partially salt neutralized ionomer; and a polymeric film comprising polyurethane and having opposed sides, wherein one of said sides of the polymeric film in at least in partial contact with said heat sealable layer, methods of making the same as well as other variations.