Multi-Layer Adhesive Patch for Medical Device Wear Life

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Solution Overview

Problem

Existing medical devices with adhesive patches, such as infusion sets and continuous glucose monitors, face issues with adhesive patch peeling off due to environmental factors like water, leading to reduced wear life and user inconvenience.

Innovation Solution

A medical device with an extended wear adhesive patch featuring a layered structure comprising a first backing layer for ultrasonic welding, a first adhesive layer, a flexible water-resistant second backing layer, and a biocompatible second adhesive layer, which provides resistance to environmental factors while maintaining user comfort.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a single-layer adhesive patch is used to couple the medical device to the user's body, then the device can be easily applied, but the adhesive patch peels off due to environmental factors like water, reducing wear life

Engineering Contradiction:
Improveease of applicationVSAvoidadhesive bond stability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The adhesive patch is divided into multiple functional layers: a first adhesive layer for initial bonding, a water-resistant intermediate layer to prevent water infiltration, and a second adhesive layer for enhanced adhesion. This segmentation allows each layer to perform its specific function, preventing the peeling issue while maintaining ease of application.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The adhesive patch uses a composite structure combining different materials with complementary properties: adhesive materials for bonding, hydrophobic materials for water resistance, and biocompatible materials for skin contact. This composite approach resolves the contradiction by integrating multiple functions into a single patch structure.

Inventive Principle:
Principle #40Composite materials

2Duration of action of stationary object

If the adhesive patch is made more resistant to water and environmental factors, then wear life is extended, but user comfort may be compromised

Engineering Contradiction:
Improvewear lifeVSAvoiduser comfort
Core Design Contradiction:
Duration of action of stationary objectVSEase of operation

Solution Approach 1:

Different regions and layers of the adhesive patch have different properties tailored to their specific functions: the intermediate layer provides water resistance where needed, while the adhesive layers provide bonding where required, and biocompatible materials provide skin contact comfort. This local differentiation allows extended wear life without compromising user comfort.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent changes the physical and chemical parameters of the adhesive patch by introducing a water-resistant intermediate layer with hydrophobic properties. This parameter change (adding water resistance) extends wear life while the biocompatible outer layer maintains user comfort during extended wear.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If a multi-layer adhesive patch structure is implemented to prevent peeling, then reliability is improved, but device complexity increases

Engineering Contradiction:
Improveadhesive patch retentionVSAvoidpatch structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The adhesive patch is segmented into distinct functional layers, each with a specific purpose. This segmentation improves reliability by ensuring each layer performs its function, while the modular nature of the segmentation keeps the overall structure manageable and not overly complex.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The composite structure combines multiple materials in a systematic arrangement. While this increases complexity compared to a single-layer patch, the organized composite structure with clearly defined layers and interfaces keeps the complexity manageable and justified by the significant improvement in adhesive retention reliability.

Inventive Principle:
Principle #40Composite materials

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 adhesive patch significantly increases the wear life of medical devices to up to 8 days, withstands water-based activities, and reduces peeling, maintaining user comfort and reducing the need for frequent replacements.

Implementation Method 1

The adhesive patch includes a first backing layer to be ultrasonically welded to the hub

Methodology Applied
Scientific EffectUltrasonic welding: Ultrasonic Vibration

Data Source

PatentEP3787712B1Medical device with extended wear adhesive patch
Publication Date: 2023.12.20 MEDTRONIC MINIMED INC
  • EP3787712B1 patent drawingFigure 1
  • EP3787712B1 patent drawingFigure 2
  • EP3787712B1 patent drawingFigure 3

AI summary

An adhesive patch for a medical device having a hub, such as an infusion device, is provided. The adhesive patch includes a first backing layer to be coupled to the medical device. The first backing layer is composed of a first material. The adhesive patch includes a first adhesive layer coupled to the first backing layer and a second backing layer coupled to the first adhesive layer. The second backing layer is composed of a second material, and the second material is different than the first material. The adhesive patch includes a biocompatible second adhesive layer coupled to the second backing layer, and the second adhesive layer is to be coupled to an anatomy.