Dual On-Body Securement for Medical Device Stability
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Solution Overview
Problem
Medical devices, such as continuous analyte monitoring systems, often become dislodged from the skin due to vigorous exercise or adhesive weakening, posing risks and causing user concern about continuous glucose monitoring.
Innovation Solution
The use of dual on-body securement elements with adhesive and non-adhesive areas, including release liners, to securely maintain medical devices like analyte sensors in place on the skin, ensuring stability and ease of use even in areas not in direct line of sight.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If adhesive is used to attach medical device to skin, then device is initially secured in place, but adhesive weakens over time causing device dislodgement
Solution Approach 1:
The securement system is divided into multiple functional layers: a mounting unit with adhesive for initial attachment, and an overbandage layer for reinforcement. This segmentation allows each layer to perform its specific function - the adhesive provides initial bonding while the overbandage maintains long-term securement without relying solely on adhesive strength.
Solution Approach 2:
The overbandage acts as a preemptive reinforcement layer applied after initial adhesive attachment but before adhesive weakening occurs. It provides additional mechanical support and distributes forces away from the adhesive interface, preventing dislodgement that would otherwise occur as adhesive degrades over time.
2Ease of operation
If vigorous exercise is performed, then device may become dislodged from skin, but device needs to remain secure during activity
Solution Approach 1:
The overbandage provides preemptive reinforcement against mechanical stresses from exercise. By applying this additional securing layer before physical activity, the system distributes shear and tensile forces across a larger area, preventing dislodgement during vigorous movement that would exceed adhesive bonding capacity alone.
Solution Approach 2:
The securement system combines different materials with complementary properties: adhesive material for chemical bonding to skin, and overbandage material (fabric or elastic material) for mechanical reinforcement. This composite approach provides both chemical and physical securement mechanisms that work together to resist forces during exercise.
3Reliability
If dual securement elements are used, then device stability is improved, but device complexity increases
Solution Approach 1:
The mounting unit itself is segmented into functional components: an adhesive layer for attachment and an overbandage layer for reinforcement. This segmentation allows the complex securement function to be achieved through simple, distinct layers that are easy to apply and remove, rather than a single complex securing mechanism.
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 solution effectively secures medical devices on the body, reducing the risk of dislodgement and providing ease of application and removal, enhancing user confidence in continuous analyte monitoring.
Implementation Method 1
The mounting unit includes an adhesive for attachment to a skin surface
Data Source
AI summary
Devices and methods for maintaining a medical device on-body are provided. Embodiments include medical device securement systems having first and second on-body securement elements. Also provided are systems and kits for use maintaining a medical device on-body.