Printed Battery Integration in Sterilized Subcutaneous Access Devices
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Solution Overview
Problem
The development of subcutaneous access devices, such as insulin pumps and continuous analyte sensors, faces challenges in miniaturization due to the need for stiff materials and standardized geometries to ensure reliable battery contact, which complicates the integration of batteries and housing, especially when aiming for sterilization and radiation resistance.
Innovation Solution
A method involving the production of a sterilized subcutaneous access device with a printed battery on a flexible carrier material, which is radiation sterilized together with the device, allowing for miniaturization and integration without the need for additional shielding, using techniques like silk screen printing for conductor paths and antenna devices, and employing batteries like zinc-manganese dioxide or lithium-sulphur dioxide.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard commercial batteries with standardized geometries are used to ensure reliable contact, then contact reliability is improved, but device complexity and installation space increase
Solution Approach 1:
The battery is integrated directly into the device housing as a printed battery structure, eliminating the need for separate battery compartments and standardized battery geometries. The battery electrodes are printed directly on the circuit board or housing interior surface, merging the power source with the device structure itself.
Solution Approach 2:
The battery utilizes thin-film printed electrodes and flexible carrier materials instead of rigid standardized battery cells. This allows the battery to conform to the device housing geometry and simplifies integration while maintaining reliable electrical contact through flexible conductive pathways.
2Reliability
If stiff materials are used for housing and contacts to ensure prolonged shelf life, then reliability is improved, but miniaturization becomes difficult
Solution Approach 1:
The device employs flexible printed circuit boards and thin-film battery structures that provide sufficient mechanical stability for shelf life while occupying minimal space. The flexible materials maintain reliable electrical connections without requiring the bulk of stiff traditional housing materials.
Solution Approach 2:
The device housing and structural elements utilize composite materials that combine the mechanical properties needed for shelf life stability with reduced thickness. Multi-layer printed circuit boards and composite battery structures provide both durability and miniaturization.
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
Enables the production of compact, sterilizable subcutaneous access devices with functional batteries that maintain performance post-sterilization, simplifying device preparation and use by integrating batteries directly onto the device carrier unit, ensuring reliable operation and adherence to the skin.
Implementation Method 1
The device carrier unit as whole is sterilized by radiation sterilization. In the process of applying the radiation for sterilization, the printed battery is exposed to the radiation applied.
Data Source
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AI summary
The application relates to a method for producing a sterilized subcutaneous access device (1), the method comprising: producing a device carrier unit (4), comprising providing a carrier, producing a subcutaneous access part (2) on the carrier, the subcutaneous access part (2) being provided with at least one of a sensor device (5) for detecting an analyte present in a bodily fluid and an infusion device (6) for infusion of a substance, and producing an electronic assembly (3) on the carrier, the producing comprising printing a battery (16) on a carrier material, and sterilizing the device carrier unit (4) by radiation sterilization, the sterilizing comprising exposing the printed battery (16) to the radiation applied for sterilization. Furthermore, the application relates to a sterilized subcutaneous access device.