Sterile Glucose Sensor Calibration via Segmented Fluid Delivery
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Solution Overview
Problem
Current medical glucose sensors require complex and time-consuming calibration processes that compromise sterility, especially when calibrating invasive or implantable devices, and existing sterilization methods can degrade glucose solutions, necessitating on-site preparation of calibration fluids.
Innovation Solution
A sterile calibration process and kit for glucose sensors that include a calibration unit with pre-prepared sterile calibration fluids of different glucose concentrations, allowing for quick and sterile calibration by flushing and propelling these fluids through the sensor, maintaining sterility and reducing user preparation time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If glucose-containing calibration solutions are sterilized with heat or gamma-radiation at manufacture, then sterility is achieved, but glucose degrades
Solution Approach 1:
The calibration solution is divided into two separate components: a sterile base solution (sterilized without glucose) and solid glucose. The sterile base solution is prepared and sterilized separately, then solid glucose is added at the point of use to create the calibration solution, avoiding glucose degradation during sterilization while ensuring sterility
Solution Approach 2:
The base solution is prepared and sterilized in advance without glucose, and all necessary components are ready for assembly. At the point of use, solid glucose is simply added to the pre-sterilized base solution, eliminating the need for time-consuming dissolution and equilibration periods while maintaining both sterility and glucose integrity
2Reliability
If solid glucose is provided and users make up calibration solutions at point of use, then sterility is maintained, but calibration time increases to over 45 minutes
Solution Approach 1:
The base solution is pre-prepared and sterilized in advance with all necessary components ready. Solid glucose is provided in a form that dissolves rapidly, and the system is designed so that mixing and equilibration are completed within seconds rather than minutes, reducing total calibration time while maintaining sterility
Solution Approach 2:
The calibration solution preparation is rushed through by using pre-sterilized base solution and solid glucose that dissolves rapidly. The mixing process is optimized to achieve complete dissolution and equilibration in seconds by vigorous mixing, skipping the lengthy 45-minute period previously required
3Measurement precision
If complex calibration steps are required, then calibration accuracy can be maintained, but user errors increase and process becomes time-consuming
Solution Approach 1:
The system is designed to be self-calibrating with minimal user intervention. The calibration unit automatically manages the calibration process, including fluid delivery, mixing, and measurement, while the user simply initiates the process. This maintains calibration accuracy through automated control while dramatically simplifying user operation
Solution Approach 2:
Multiple calibration steps are merged into a single integrated process. The calibration unit combines fluid delivery, mixing, equilibration, and measurement into one automated sequence, eliminating the need for users to perform separate manual steps while maintaining the accuracy requirements of each individual step
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 rapid, sterile calibration of glucose sensors under point-of-use conditions without compromising sterility, eliminating the need for user-prepared solutions and simplifying the calibration process, thereby improving accuracy and efficiency.
Implementation Method 1
a fluid propulsion means for propelling calibration fluid from the calibration chambers to the sensing zone
Data Source
AI summary
A process for calibrating a glucose sensor under sterile conditions includes providing separate, sterile, glucose-containing calibration fluids, each having a different glucose concentration, and in turn providing these fluids to a sensing zone containing a sensing probe of a glucose sensor. Each solution is typically, in turn, propelled into the sensing zone, thus flushing out used fluid already present in the sensing zone. The process provides rapid calibration of a glucose sensor in a sterile fashion and is therefore appropriate for point-of-use calibration.