Stabilized Enzyme Layer for ETO Sterilization
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Solution Overview
Problem
Existing medical devices with biologically active components, such as analyte sensors, face degradation during sterilization processes like ethylene oxide (ETO) sterilization, leading to reduced biological activity and effectiveness.
Innovation Solution
A stabilized medical device is created with a substrate having a stabilized enzyme layer that includes a biologically active sensing component non-covalently combined with a stabilizing component, such as trehalose, diethylaminoethyl-dextran hydrochloride, or sorbose, which maintains biological activity levels between 45% to 95% after ETO sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ethylene oxide sterilization is applied to medical devices with biologically active components, then sterilization effectiveness is improved, but biological activity of the components deteriorates
Solution Approach 1:
The patent applies preliminary action by incorporating stabilizing components (such as sugars, polyols, or amino acids) into the biological components before sterilization. These stabilizers are pre-bound to the enzymes or antibodies, forming a protective complex that prevents denaturation during the subsequent ethylene oxide sterilization process, thereby maintaining biological activity while achieving sterilization
Solution Approach 2:
The stabilizing components act as intermediaries between the ethylene oxide sterilization agent and the biologically active components. These intermediaries (stabilizers) absorb or mitigate the harmful effects of ethylene oxide on the biological molecules, allowing sterilization to proceed while protecting the enzymes or antibodies from degradation
2Reliability
If multiple sterilization cycles are applied to medical devices, then sterilization completeness is improved, but degradation of biological components worsens
Solution Approach 1:
By pre-incorporating stabilizing components into the biological components before sterilization, the patent creates a protective shield that allows multiple sterilization cycles to be performed without cumulative degradation. The stabilizers remain bound throughout repeated sterilization processes, maintaining enzyme or antibody integrity across multiple cycles
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 ensures that the biologically active sensing components retain a significant level of activity post-sterilization, enhancing the performance and accuracy of medical devices like analyte sensors and biobatteries by preventing degradation during sterilization and storage.
Implementation Method 1
at least one stabilizing component non-covalently combined with the biologically active sensing component
Data Source
AI summary
The present disclosure relates generally to stabilized medical devices having immobilized biologically active entities necessary for sterilization. The present disclosure provides a substrate (200) that is at least partially electrically conductive, and a stabilized enzyme layer (220) disposed over at least a portion of a surface of the substrate. The stabilized enzyme layer (220) may include at least one biologically active sensing component (240), such as glucose oxidase in the case of glucose sensors, and at least one stabilizing component (260) non-covalently combined with the biologically active sensing component (240). The present disclosure further provides the biologically active sensing component (240) having a biological activity detection level from about 25 U/cm3 to about 1,000,000 11/ cm3 of the substrate following ethylene oxide sterilization of the biologically active sensing component. The present disclosure further provides methods of making stabilized medical devices having immobilized biologically active entities.