Analyte Sensor Sterilization via Electron Beam Irradiation
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Solution Overview
Problem
Existing sterilization techniques for medical devices, particularly those implanted or positioned beneath the skin, face challenges in achieving effective sterilization across diverse materials and packaged configurations, including maintaining sterility assurance levels and avoiding damage to components during the process.
Innovation Solution
The method involves assembling an analyte sensor with a sensor insertion device, packaging it in a container with airtight seal, and irradiating the assembly using electron beam sterilization to achieve a sterilization dose effective for the packaged components, ensuring a long shelf life and maintaining the integrity of materials and adhesives.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional sterilization methods (chemical or irradiation) are used to achieve desired sterility assurance level, then sterilization effectiveness is improved, but material compatibility and component integrity deteriorate due to damage to diverse materials including metals, plastics, biologics, and chemistries
Solution Approach 1:
The patent applies electron beam irradiation with controlled dosage parameters (25-40 kGy) to achieve sterilization while minimizing material damage. By precisely controlling the energy parameters of the irradiation process, the method achieves effective sterilization (SAL ≤ 10^-6) without adversely impacting sensitive materials such as adhesives, biologics, and packaging materials, thus resolving the contradiction between sterilization effectiveness and material integrity
Solution Approach 2:
The patent replaces traditional mechanical or chemical sterilization methods (autoclaving, chemical exposure) with electron beam irradiation technology. This substitution enables sterilization of packaged devices without requiring unpacking or exposure to harsh chemical environments, thereby protecting materials from damage while achieving the required sterility assurance level
2Reliability
If sterilization is performed on unpackaged devices, then sterilization effectiveness is improved, but device complexity and packaging requirements worsen due to additional packaging steps and sterility maintenance needs
Solution Approach 1:
The patent performs sterilization as a preliminary action before final packaging or distribution. By sterilizing devices in their final packaging configuration using electron beam irradiation, the process eliminates the need for separate sterilization and packaging steps, reducing overall process complexity while maintaining sterility assurance. The packaging itself becomes part of the sterilization containment system
Solution Approach 2:
The patent merges the sterilization process with the packaging process by irradiating devices in their final packaged state. This consolidation of operations eliminates intermediate handling steps, reduces the number of process steps required, and ensures that the packaging material itself is sterilized along with the device, thereby simplifying the overall manufacturing workflow
3Duration of action of stationary object
If high sterilization doses are applied to achieve long shelf life, then shelf life is improved, but material degradation worsens affecting adhesives and packaging materials
Solution Approach 1:
The patent optimizes the electron beam irradiation dosage parameters to achieve the desired shelf life extension (approximately 18 months) while maintaining adhesive integrity. By controlling the dosage within the range of 25-40 kGy and adjusting beam energy parameters, the process achieves sufficient sterilization and shelf life extension without causing excessive material degradation or compromising adhesive bonding strength
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 approach results in a sterilization process that achieves a high sterility assurance level (10^-6) with a long shelf life of approximately 18 months, without adversely impacting the materials or adhesives, ensuring the packaged analyte sensor and sensor insertion device remain sterile and functional.
Implementation Method 1
irradiating the packaged assembled analyte sensor and sensor insertion device at a dose effective to sterilize the package
Implementation Method 2
irradiating the packaged assembled analyte sensor and sensor insertion device at a dose effective to sterilize the package
Data Source
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AI summary
In one aspect, there is provided assembling an analyte sensor with an analyte sensor insertion device, packaging the assembled analyte sensor and sensor insertion device in a substantially airtight seal, and irradiating the packaged assembled analyte sensor and sensor insertion device at a predetermined dose using one or more electron beam accelerators.